RESULTS

AND
DISCUSSION
 It is evident from the literature that preconditions for

malnutrition exist in the general population, which has serious

implications in a clinical setting where a low nutritional status

adversely affects the treatment efficacy, overall outcome and

hospitalisation costs. In addition, considerable degree of malnutrition

has been reported among hospitalised patients attributable to both,

the disease process itself and the medical therapy. Moreover,

patients tend to 'starve' due to various physiological and

psychosocial reasons resulting in low nutritional status. Appropriate

nutritional care has been shown to reverse malnutrition and improve

prognosis. Recent advances in nutritional support have emphasised

the benefits of nutritional care, making it an integral part of medical

therapy. Nutritional support may be initiated in the critically ill

patient using parenteral or enteral nutrition routes. Enteral

feeding is the preferred route for nutritional support due to

fewer infectious complications and better outcomes associated

with it. The clinical usefulness of this form of nutrient delivery

has been enhanced by the development of disease-specific

enteral foods.

Hence the present study was carried out in selected hospitals

having ICU units to evaluate the available nutrition support systems

for patients requiring critical care. Based on the nutritional need-

assessment conducted in 100 patients, food formulations using

123
natural foods supplemented with disease-specific nutraceuticals

were designed. These formulations were suitable for both oral as well

as tube feeding through Ryle's tube (RT). The food formulations were

evaluated for their physico-chemical characteristics, acceptability,

nutrient profile, starch and fibre fractions and nutritional quality.

A total number of four formulations viz., general and disease-

specific (diabetes, cancer and HIV/AIDS) were prepared. These were

clinically tested for their efficacy in human volunteers who were

under critical care.

The results based on the above investigation are presented in

three sections:

I - Nutritional support systems in selected hospitals and

nutrition need-assessment of hospitalised critically ill

patients

II - Processing and formulation of enteral foods and their

nutrient composition, acceptability and quality evaluation

III- Effect of feeding formulated foods in general and specific

disease group patients under critical care.

124
I. NUTRITIONAL SUPPORT SYSTEMS IN SELECTED
HOSPITALS AND NUTRITION NEED-ASSESSMENT OF
HOSPITALISED CRITICALLY ILL PATIENTS

Nutritional needs of the patients were assessed using

environmental and dietary status criteria are presented in Table 16.

Among the patients, 58 were men and 42 were women with a

majority of them in the 40-50 yrs age group. The patients were from

the surgical and non-surgical ICUs and were admitted for various

reasons. However, a study of the conditions present in the patients

including primary diagnosis and/or co-morbidities revealed that 3 1 %

had diabetes and 18% suffered from hypertension. Of the remaining,

6 were HIV positive and two women had developed AIDS.

An evaluation of nutritional support extended to patients

under critical care showed that none of the hospitals were equipped

totally to meet the patients' nutritional needs. This could be

attributed to the fact that these hospitals did not have a well-

resourced hospital dietary which could effectively support nutritional

care. It was also observed that these patients were being given

blenderised food along with commercial formulas. In a few cases,

patients were receiving feeds from their homes. Hence, existing

nutritional support systems were not specific to the patients'

nutritional needs. Moreover, the feeds were being specified by the

doctors rather than the dieticians which served the purpose of only

125
Table 16. Age group of patients and disease conditions

No. o f p a t i e n t s
Men Women Total
Age g r o u p
18-30 10 08 18
30-40 15 16 31
40-50 29 16 45
50-60 04 02 06
Incidence of:
Diabetes 18 13 31
Hypertension 11 07 18
CHD/IVD 06 05 11
Cancer 07 05 12
HIV/AIDS 03 05 08

126
satisfying "hunger" rather than therapeutic needs. Details of

nutritional support in terms of mode and type of feeding are

presented in Table 17.

It could be seen that 44% of all critically ill patients received

enteral nutrition and 88% receive parenteral nutrition. These figures

reveal overlapping cases of nutritional support because parenteral

nutrition (PN) is a common route of nutritional support in India and

is routinely used in most critically ill patients. Of the patients

receiving enteral nutrition (EN), a majority received nutrition by

bolus feeding with an average of 5-8 feeds per day depending on total

feed volume and feed tolerance. The volume per feed ranged from

150-350 ml with a mean of 242ml. The total feed volume ranged

from 1800-2750ml with a mean of 2319ml. A significant finding is

that while all patients on EN received it post-operatively, only 13.6%

of patients received EN pre-operatively and none received EN peri-

operatively. All these patients received blenderised hospital diets with

40% of patients having their diet partially supplemented with

commercial enteral formulations and 6.8% of the patients completely

on commercial feeds. It must be noted here that these patients who

were completely on commercial formulations were on continuous

feeding using an enteral pump. It was observed that the doctors did

not recommend blenderised food for the patient as there was a

possibility of its clogging the tube.

127
Table 17. Details of nutritional support of patients
M o d e / T y p e of feeding No. (%) of p a t i e n t s
Enteral feeding 44
Continuous feeding 3 (6.8)
(pump)
Bolus feeding 41 (93.2)
Pre-operative 6 (13.6)
Peri-operative -
Post-operative 44 (100)
No. of feeds 5-8
Volume per feed 2 4 2 ± 2 3 ml
(150-350ml)
Total volume of feeds 2319±46ml
(1800-2750ml)

Hospital-blenderised food 44 (100)

Commercial formula
Partial 18 (40.9)
Total 3 (6.8)

Parenteral nutrition 88
Central 14 (15.9)
Peripheral 74(84.1)
Pre-operative 34 (36.6)
Peri-operative 8 8 (100)
Post-operative 8 8 (100)

128
 With regard to patients receiving PN, a majority of the patients

(84.1) received PN through peripheral parenteral nutrition (PPN), with

the remaining 15.9% receiving central or total parenteral nutrition

(TPN). This is because PN was used only for a limited duration, often

less than 3 days-generally a day pre- and post-operatively, when

surgical protocol advocates nil per oral or NPO.

The environmental characteristics of the patients are presented

in Table 18. A majority of the patients (89%) lived in nuclear

families. More than half the patients (56%) had an educational level

of up to PUC, 13% had no formal education and about a third having

completed graduation (17%) or post graduation (14%). Literacy levels

of men were significantly higher to that of women. The educational

status also reflected in the income levels of the patients, which

showed that 47% had an income between Rs. 5000-10,000, 2 1 % had

a level of above Rs. 10,000 while 10% had a level below Rs. 2000 per

month. With regards to health habits, 23% of the patients were

smokers, 9% chewed tobacco and 11% consumed alcohol. Most of

these were men with only one woman who reported to be a smoker

while two women reported chewing tobacco.

The retrospective data on the frequency of food consumption of

patients (Table 19) showed that while cereals were consumed daily

by all patients, pulses were consumed by only 80% daily while the

129
Table 18. Environmental characteristics of patients and
their health habits

No. o f p a t i e n t s
Men Women Total
Type of family
Nuclear 53 36 89
Joint 05 06 11
Educational status
No formal education 05 08 13
Below matriculation 08 11 19
PUC 22 15 37
Graduation 11 06 17
Post-graduation 12 02 14
Household income (pm)
<2000 05 05 10
2000-5000 14 08 22
5000-10,000 25 22 47
>10,000 14 07 21
Health h a b i t s
Smoking 22 01 23
Chewing tobacco 07 02 09
Drinking/Alcoholism 11 00 11

130
 Table 19. Frequency of retrospective food consumption of
patients
Food item DaUy Twice/ Weekly Fortnightly Monthly Never
week
Cereals 100 - - - - -

Ragi - - - 38 08 18
Wheat 24 16 23 - - -
Rice 38 21 19 - - -

Pulses 80 20 - - -

Green leafy veg 43 09 13 12 18 05

Roots 8& tubers 39 22 18 17 - 04
Other veg 74 21 05 - - -

Fruits 55 - 10 12 17 06
Milk 68 20 - - - 12
Meat - - 01 32 02 65
Chicken - - 01 17 - -
Mutton - - - 12 - -
Others - - - 03 02
Eggs 02 04 11 19 - 64
Fats 100 - - - - -
Ghee - - 29 - - 12
Coconut oil - - - 05 - 95
Other oil 100 - - - - -
Sugar/Jaggery 99 - - - - 01

131
rest 20% consumed it at least twice a week. Rice was the

predominant cereal consumed followed by wheat. Ragi was

consumed less frequently than rice or wheat. Less than half the

patients consumed GLVs or roots and tubers daily with 18%

consuming GLVs only monthly and 9% not consuming any GLV or

roots and tubers. While all patients reported consuming other

vegetables, only 74% consumed them daily. The consumption of

fruits was infrequent with 55% consuming some fruit everyday viz.,

banana. Six patients reported that they did not consume any fruit

due to personal dislike. Milk was consumed by 88% of the patients

with 12% saying they did not consume any milk due to aversion and

'allergy'. However, none of the patients reporting allergy had tested

and confirmed the allergy medically. Only 35% of the patients were

non-vegetarian and a majority of them preferred chicken (18%) or

mutton (12%). Five of the patients reported consuming other meat

also, notably rabbit and pheasant. Although 65% of the patients

reported no consumption of meat, 64% of all patients reported

consumption of eggs suggesting that many patients consumed eggs

and not meat, and could be categorised as lacto-ovo-vegetarians.

The mean dietary intake of the patients (Table 20) was

calculated around a 24-hr dietary recall of their retrospective diet

before admission to the hospital. The data revealed that except for

the intake of fats and oils and meat in men, the intake of all other

132
 Table 20. Mean dietary food intake of patients* (g)
Food item Men Women
Intake DDP Intake DDP
Cereals 340 ± 26.3 375 310 ± 18.8 345
Pulses 50 ± 17.5 60 40 ± 14.1 50
GLVs 40 ± 33.4 80 30 ± 22.2 75
Roots and tubers 45 ± 16.6 50 40 ± 18.4 45
Other vegetables 50 ± 13.4 50 30 ± 13.3 45
Fruits 15 1 2 0 . 5 50 15 ± 18.9 40
Milk (ml) 130 ± 32.7 200 100 ± 37.5 175
Meat 45 ± 18.2 40 25 ± 19.6 35
Fats and oils 30 ± 20.7 30 25 ± 11.9 25
Sugar/Jaggeiy 25 ± 17.7 25 20 ± 16.5 25
- Retrospective inltake - before t leir admi ssion to ICU

133
food groups in men and women was below the desirable dietary

pattern (DDP). The largest deficits are seen in the consumption of

fruits (<l/3'-d DDP), GLVs (<l/2 DDP) and milk in (<2/3'-d DDP) that

order.

The energy and nutrient intake of the patients is shown in

Table 21 reflected the food intake computed. As expected, the diet

was deficient in all macro and micro-nutrients. An energy deficit of

about 120 kcal per day in men and - 2 7 3 kcal in women was

apparent. The micronutrients - iron, retinol and B-vitamins showed

the largest deficits.

The classification of patients based on the percent nutrient

adequacy (PNA) is presented in Table 22. Most of the patients had a

PNA of <90 for almost all the nutrients. A majority of patients

showed a PNA of <50 for iron (36%) and thiamine (38%) followed by a

PNA of 51-70 for protein (64%), calcium (53%), retinol (46%), B2

(51%) and B3 (41%). PNA of energy, fat and ascorbic acid is between

71-90 for a majority of the patients. A very small proportion of the

patients have a PNA of above 91 with a maximum of 12 patients

sowing >91 PNA for energy intake.

The index of nutritional quality of the diet is indicative of the

quality of diets of the patients expressed per 1000 kcal intake. On

134
 Table 2 1 . Mean nutrient intake of patients vis a vis RDI

Nutrient Men Women Total

Mean RDI Mean RDI Mean RDI

Energy (Kcal) 1905 ± 2125 ± 1712 ± 1985± 1780 ± 2085 ±

154.6 88.6 195.8 111.8 185.4 96.8

Protein (g) 59 ± 62.8± 44 ± 51.6± 50 ± 13.6 58 ±

12.5 12.6 12.9 15.6 15.7

Fat (g) 36 ± - 26 ± - 30 ± 10.7 -

11.6 10.4

Carbohydrate 355 ± - 295 ± - 325 ± -

(g) 44.8 41.3 45.7

Calcium (mg) 250 ± 400 210 ± 400 225 ± 400

131.0 136.7 126.3

Iron (mg) 25 ± 28 14 ± 30 15 ± 29
11.7 14.5 12.70

Retinol (|ig) 370 ± 600 310 ± 600 340 ± 600

125.4 110.8 120.7

Ascorbic acid 38 ± 40 29 ± 40 31 ± 40
(mg) 12.4 14.0 13.5

Thiamine (mg) 0.9 ± 1.2±0.5 0.7 ± 0 . 5 1.0±0.4 0.8 ± 0.7 1.U0.5

0.6

Riboflavin (mg) 1.0 ± 1.3±0.6 0.9 ±0.9 1.1±0.7 0.9 ± 0 . 9 1.2±0.7

0.8
Niacin (mg) 13 ± 7 . 4 15±8.1 10 ± 13±8.5 12 ± 11.3 14±9.1
12.3
* RDI - Values are mean o f RDI com Duted usi]ag ICMR r<scommenc ations

135
Table 2 2 . Percent nutrient adequacy (PNA) of diet of subjects

Nutrient No. of subjects

<50 51-70 71-90 >90
Energy 10 21 57 12
Protein 09 64 23 04
Fat 11 32 49 08
Calcium 27 53 19 01
Iron 36 34 21 09
Retinol 41 46 10 04
Thiamine 38 35 22 05
Riboflavin 36 51 13 00
Niacin 31 41 27 01
Ascorbic acid 23 21 45 11

136
this basis, the INQ of protein and ascorbic acid is found to be the

highest at 0.8 with that of iron and retinol being the lowest at 0.3

(Figure 16).

Body size measurements were used as a yardstick to evaluate

the nutritional status of patients. Table 2 3 shows the mean

anthropometric measurements and indices of patients, the percentile

classification of patients by BMI, MUAC, SFT and MUAMC are

presented in Tables 2 4 & 25.

Percentile classification by body mass index (BMI) indicated

42% of the patients were showing chronic energy deficiency. More

number of women (28%) were found to be malnourished by this

criteria. Similarly, though 38% of the patients were in the normal

range, more number of men (24%) were found to be in normal energy

status than women. A small percentage of patients were found to be

overweight (11%) and obese (9%).

Percentile classification of patients by MUAC and MUAMC

indicators of protein status showed more number of patients having

low protein status ranging between 70-90% of the normal. While 46%

of the patients were having normal protein status by the criteria of

MUAC, the number reduced to 36% when MUAMC, which is a better

indicator was used to assess the protein status.

137
standard/
1 0 0 0 Kcal Nutrient

J Ascorbic acid |0.8

^ Niacin |0.4
to

Of
J Riboflavin i^^MO.6
d

J Thiamine |0.6
o

o Retinol |0.3
<D

O)

1 Iron Qmmm^io.3
o Calcium I^^Bo.6

jg Protein B|0.8
<'
0 0.2 0.4 0.6 0.8 1.2
Nutrients as proportion of energy

Figure 16. Nutrient profile of the patients based on recommend

allowance/lOOOKcal - Index of Nutritional Quality

138
 Table 2 3 . Mean (±SD) anthropometric measurements and
indices of the selected patients
Measurement/ indices Men Women
(n=58) (n=42)
Height (cm) 160.3 + 9.3 149.7 ± 12.4
Weight (kg) 62.3 ± 11.6 51.7 ± 13.0
Body Mass Index 23.6 ± 9 . 8 22.8 ± 8 . 6
MUAC (cm) 31.6 ± 13.9 33.4 ± 14.7
Skin fold thickness (mm) 19.6 ± 3 . 6 21.5 ± 4 . 8
MUAMC (cm) 24.6 ± 11.4 21.3 ± 9 . 8

Table 2 4 . Percentile Classification of the selected patients by

BMI
BMI No. of patients
Men Women Total
<18.5 14 28 42
18.5-24.9 24 14 38
25-29.9 04 07 11
30-34.9 05 04 09

139
Table 2 5 . Percentile Classification of t h e selected p a t i e n t s
by MUAC, MUAMC and SFT
(No.)
Classification Men Women Total
MUAC
<60 - 02 02
61-70 06 03 09
71-80 09 11 20
81-90 12 11 23
>90 31 15 46
MUAMC
<60 - 01 01
61-70 04 - 04
71-80 11 15 26
81-90 17 16 33
>90 26 10 36
SFT
<60 - 01 01
61-70 04 01 05
71-80 10 14 24
81-90 18 13 31
>90 26 13 39

140
 Fat status of these patients by the criteria of skin fold is also

presented in Table 25. Again, higher percentage of patients (55%)

showed a fat status ranging between 70-90% of normal. Thirty nine

percent of the patients could be classified as having a normal fat

status. It was observed that more number of men were showing

normal protein and fat status when compared to women.

Thus, more than 50% of patients under critical care were

showing varying degrees of protein-energy malnutrition, particularly

women.

The feedback elicited from attending doctors or dieticians

regarding mode of nutritional support and enteral nutrition in

particular is summarised in Table 26. All respondents felt that there

is a need for specialised enteral products that are condition-specific

and supplemented with foods or food components to improve

nutritional replenishment and aid medical therapy. A high number of

respondents said they prefer EN to PN when enteral access is

possible.

When asked about the barriers to using EN in clinical settings,

a majority of them (83.3%) expressed that the cost of specialised

nutrition products available in the market to be the top barrier.

While 25% of them cited the nutritional quality as a factor limiting a

141
Table 26. Feedback from doctors/dieticians
regarding enteral nutrition
%
respondents
Need for specialised enteral 100
products
Barriers to use of enteral feeds
Nutritional quality 25.0
Availability 16.6
Complications 16.6
Cost 83.3
Preference of EN over PN 91.6

142
wider use of EN with an equal number (16.6%) mentioning

availability of such enteral formulations and the complications

associated with EN respectively to be the barriers to the adoption of

EN in hospitals.

Discussion

The results of the preliminary study clearly indicate the

prevalence of protein and energy malnutrition among the

hospitalised patients as assessed by the dietary intake and somatic

status. It was evident from the retrospective dietary records that the

food intake was simplistic and low amounts of micronutrient sources

were being consumed, which perhaps resulted in a lower intake of

protein and micronutrients. It was also seen that more than 50% of

the patients had an energy deficit between 70 and 90% with only

12% showing an energy adequacy of more than 90%. Thus, most of

the patients were in the category of chronic energy deficiency. The

most favourable adaptive response under normal conditions when

energy requirement cannot be met is maximal derivation of energy

from fat stores. In the present study, it was observed that more

number of patients were showing low protein fat status as indicated

by MUAMC (64%) than by SFT (61%) measurement. Thus, it can be

assumed that these patients were subsisting on a deficient diet for a

long period of time.

143
 Since malnutrition considerably alters cellular immunity,

which results in increased susceptibility to opportunistic infections

(26, 53), it is necessary that every effort be made to assess the

nutritional needs of the individual patient for the planning of

nutritional support.

II. PROCESSING AND FORMULATION OF ENTERAL

FOODS, THEIR NUTRIENT COMPOSITION,
ACCEPTABILITY AND QUALITY EVALUATION

A. NUTRIENT COMPOSITION OF THE RAW FOOD INGREDIENTS

In food formulation, adoption of both primary and secondary

processing becomes necessary to make the formulation specific to

conditions, particularly those needing specialised nutritional

support. Since malting has been used to modify food ingredients

suitable for enteral formulation, all the base cereals and pulses

reduced the bulk density and slightly reduced the moisture content

of the ingredient on further drying.

1. Proximate composition of raw food ingredients

The macronutrient composition of the ingredients ragi, rice,

barley and green gram was similar except for the protein content

(Table 27). The protein content ranged 3.8% in ragi to 21.6% in

green gram. The other ingredients used for the formulation which

includes oats and soya flour, showed a protein content of 15.5% and

144
 Table 27. Proximate composition of raw food ingredients
(g/lOOg)*

Item Ragi Rice Barley Green Oats Soya WMP SMP

gram flour
Moisture 7.1 6.8 7.3 8.4 6.3 6.1 8.1 7.1
Protein 3.8 4.7 7.5 21.6 15.5 49.3 25.3 24.2
Fat 1.6 1.0 2.8 1.6 6.0 1.3 24.9 10.8
Total ash 2.2 1.0 1.0 2.5 1.7 6.0 5.5 6.5
Fibre 7.3 6.5 7.5 7.4 7.5 4.5 - -

Carbotiydrate** 91.3 86.6 80.0 70.6 67.5 44.6 41.6 44.0

Calcium 285.5 13.2 26.0 64.5 131.5 248.0 958.0 890.7
Phosphorus 135.6 131.1 150.7 355.5 188.4 585.7 703.6 715.3
*Values are mean of three replicates
** Carbohydrate - by difference

145
49.3% respectively with oats having similar carbohydrate

composition as that of the cereals. The carbohydrate content of soya

flour was lower than the other ingredients though it was similar to

the carbohydrate content of milk powders added to the formulations.

While the fat content of oats was higher than the other base

ingredients, it was found to be low in soya flour. Milk powders -

whole and skimmed, contributed considerable amount of protein

(>25%) to the formulations. In addition, whole milk powder had the

highest amount of fat among all the ingredients added. The added

ingredients soya flour and milk powder - whole and skimmed,

contained high amount of ash which contributed to the mineral

composition also.

Mineral composition of these ingredients is shown in Table 28.

Ragi being a rich source of calcium, had higher amounts of calcium

(285.5 mg %) compared to other base cereals and green gram. Among

the other added ingredients, soya flour had a higher content of

calcium than the oats. Besides, milk being a rich source of calcium,

milk powders contributed a significant amount of calcium to the

formulations. The phosphorus content of the base ingredients ranged

from 131.1 mg in rice to 355.5 mg % in green gram. Among the

added ingredients, it ranged from 188.4 mg % to 585.7 mg % in soya

flour. The content of phosphorus in milk was found to be above 700

mg %.

146
Table 28. Composition of major minerals of raw food ingredients
(g/lOOg)*

Item Ragi Rice Barley Green Oats Soya WMP SMP

gram flour
Calcium 285.5 13.2 26.0 64.5 131.5 248.0 958.0 890.7
Phosphorus 135.6 131.1 150.7 355.5 188.4 585.7 703.6 715.3
Total ash 2.2 1.0 1.0 2.5 1.7 6.0 5.5 6.5
*Values are mean of three replicates

147
2. Carbohydrate Profile of raw food ingredients

The carbohydrate profile of all the food ingredients is presented

in Table 29. All the foods contained low amounts of reducing and

non reducing sugars. Among the added ingredients, while the sugar

content of the oats was similar to that of cereals and the green gram,

it was still low in the soya flour. The starch content ranged from

28.5% in soya to 46.9% in rice. Total Dietary Fibre (TDF) content of

all the foods was low with soya flour having the lowest (4.5%). Total

carbohydrate content of these foods ranged from 71.9% in oats to

86.3% in ragi total carbohydrate content of soya flour was found to

be much lower - 46.2% than the other foods.

The dietary fibre content of the food ingredients in terms of

soluble and insoluble fractions in shown in Table 30. The soluble

dietary fibre content ranged from 1.6 % in soya flour to 4.6 % in

barley. The insoluble dietary fibre (IDF) content was found to be

similar ranging from 2.9 % in soya flour to 4.1 % in green gram.

3. Starch fractions of raw food ingredients

Total starch content and its content viz. rapidly digestible

starch (RDS), slowly digestible starch (SDS) and resistant starch (RS)

is given in Table 31. The RDS and SDS content of these foods were

found to be low with three of the foods. Ragi, rice and oats having a

similar content ranging between 13.5 - 16.6 % and the other three

148
 Table 29. Carbohydrate profile of the raw food ingredients
(g/lOOg)*
Fraction Ragi Rice Barley Green Oats Soya
gram flour
Reducing
18.1 17.6 20.4 11.9 13.3 5.4
sugars
Non-
reducing 15.6 13.1 17.0 15.6 16.2 7.8
sugars
Total sugars 33.7 30.7 37.4 27.5 29.5 13.2
Total starch 45.3 46.9 38.6 39.8 40.9 28.5
Total Dietary
7.3 6.5 7.5 7.4 7.5 4.5
Fibre
Total
86.3 84.1 83.5 74.7 71.9 46.2
carbohydrate
*Values are mean of three replicates
On dry weight basis

149
 Table 30. Dietary fibre content of the raw food ingredients
(g/lOOg)*
Item Green Soya
Ragi Rice Barley Oats
gram flour
Soluble 4.1
4.2 3.8 4.6 3.3 1.6
dietary fibre
Insoluble
3.1 2.7 2.9 4.1 3.4 2.9
dietary fibre
Total dietary
7.3 6.5 7.5 7.4 7.5 4.5
fibre
*Values are mean of three replicates
On dry weight basis

Table 3 1 . Total starch content and its fractions in the raw food
ingredients (g/lOOg)*
Item Green Soya
Ragi Rice Barley Oats
gram flour
RDS 12.6 9.9 13.5 18.7 5.6 3.2
SDS 14.1 16.6 7.5 6.3 13.5 6.6
RS 18.6 20.4 17.6 12.8 20.8 18.7
TS 45.3 46.9 38.6 39.8 40.9 28.5
NSP 25.9 26.9 25.1 24.2 28.3 23.2
*Values are mean of three replicates
On dry weight basis
RDS- rapidly digestible starch
SDS-slowly digestible starch
RS-resistant starch
TS-total starch
NSP- Non starch polysaccharides = resistant starch + TDF.

150
barley, oats and soya having still lower amounts ranging from 6.3 to

7.5 %. All the foods had higher amount of RS with green gram having

the least (12.8%). However, non starchy polysaccharide (NSP) was

similar, ranging from 23.2 % in soya flour to 28.3 % in oats.

Rapidly available glucose (RAG) along with starch digestibility

index (SDI) of the raw food ingredients is shown in Table 32. A wide

variation in the RAG content of these foods ranging from 8.8 % in

soya flour to 22.3 % in barley was observed. This reflected in the SDI

which also showed a wide range 11.2 % in soya flour to 35.0 % in

barley.

Total sugars, starch, dietary fibre and their fractions as

percentages of total carbohydrate in the raw food ingredients along

with their SDI are presented in Table 33. It was interesting to know

that RDS fraction and the fibre fractions were similar in all the four

base ingredients. In case of oats and soya flour, while the RDS was

low, RS content was found to be high. Except for soya flour, total

carbohydrate of the cereals and green gram was found to be similar.

However it did not fall into pattern with respect to SDS as the SDS

content of barley and green gram were much lower than other

ingredients.

151
Table 3 2 . Rapidly available glucose (RAG) and starch digestion
index (SDI) of the raw food ingredients

RAG SDI

Ragi 20.7 27.8

Rice 14.1 21.1

Barley 22.3 35.0

Green gram 15.9 47.0

Oats 9.1 13.7

Soya flour 8.8 11.2

Rapidly Digestible starch

SDI X100
Total starch

152
Table 3 3 . Total sugar, starch, dietary fibre and their fractions as
percentage of total carbohydrates in the raw food ingredients
(g/lOOg)*

Total CHO As% of total carbohydrates SDI

Ingredient TS + TDF + TSU
RDS SDS RS IDF SDF
Ragi 86.3 14.6 16.3 21.6 3.6 4.9 27.8
Rice 84.1 11.8 19.7 24.3 3.2 4.5 21.1
Barley 83.5 16.2 9.0 21.1 3.5 5.5 35.0
Green gram 74.7 25.0 8.4 17.1 5.5 4.4 47.0
Oats 71.9 7.8 18.8 30.3 0.6 1.5 13.7
Soya flour 46.2 6.9 14.3 40.5 6.3 3.5 11.2
*Values are mean of three replicates
On dry weight basis

153
B. EFFECT OF PROCESSING ON THE NUTRITIONAL
COMPOSITION OF FOOD INGREDIENTS
Raw food ingredients were subjected to processing using

malting in case of ragi, rice, barley and green gram. Toasting (dry

heat) was used for processing oats and soya flour.

1. Proximate composition of processed food ingredients

The effect of processing on the proximate composition of food

ingredients are shown in Table 34. Processing reduced the moisture

content of the foods slightly.

Malting apparently increased the protein and fat content, but

decreased the total ash and fibre content. As a consequent effect,

carbohydrate by difference showed an increase in malted food

ingredients. However in case of toasting, though the moisture

content slightly decreased, protein and fat content also showed a

decrease.

Effect of processing on mineral content of food ingredients in

Table 35. While calcium content of ragi, rice and the green gram

increased, that of barley decreased. The same effect was not seen on

the phosphorus content. While malting increased the phosphorus

content of ragi and barley, it decreased the phosphorus content of

rice and green gram. Toasting of oats and soya flour decreased both

the calcium and phosphorus content.

154
 Table 34. Effect of processing on the proximate composition of
food ingredients (g/ lOOg)*

Green Soya
Ingredient Ragi Rice Barley Oats
gram flour
Raw 7.1 6.8 7.3 8.4 6.3 6.1
Moisture
Proc. 6.8 6.6 6.2 7.8 6.1 6.0
Raw 3.8 4.7 7.5 21.6 15.5 49.3
Protein
Proc. 4.1 5.3 7.8 22.8 14.8 47.6
Raw 1.6 1.0 2.8 1.6 6.0 1.3
Fat
Proc 2.1 1.4 3.3 1.8 5.8 1.2
Raw 7.3 6.5 7.5 7.4 1.5 4.5
Fibre
Proc 5.9 5.2 4.9 5.2 1.6 4.1
Raw 91.3 86.6 80.0 70.6 67.5 44.6
Carbohydrate**
Proc. 92.0 92.6 88.1 73.7 77.6 45.3
Raw 2.2 1.0 1.0 2.5 1.7 6.0
Total ash
Proc 1.8 0.7 0.8 1.7 1.8 5.9
* Values are mean of three replicates
** Carbohydrate - by difference

J 55
Table 35. Effect of processing on the mineral composition of
food ingredients (g/ lOOg)

Ingredient Calcium Phosphorus Total ash

Raw 285.5 135.6 2.2

Ragi
Proc. 291.7 140.6 1.8
Raw 13.2 131.1 1.0
Rice
Proc. 15.6 121.8 0.7
Raw 26.0 150.7 1.0
Barley
Proc. 22.8 164.3 0.8
Green Raw 64.5 355.5 2.5
gram Proc. 74.3 312.8 1.7
Raw 131.5 188.4 1.7
Oats
Proc. 120.7 146.2 1.8
Soya Raw 248.0 585.7 6.0
flour Proc. 227.8 525.0 5.9

156
2. Carbohydrate ProHle of processed food ingredients

Effect of processing on the carbohydrate profile of food

ingredients is given in Table 36. While malting increased the

reducing sugars and non reducing sugars, toasting resulted in a

decrease in sugar content. Consequently it affected the total starch

content. While malting decreased the total starch content, toasting

increased it slightly. A similar effect was also seen in case of TDF,

where the values decreased with malting. Values remained almost

similar in case of toasting. A similar pattern of decreasing values in

the total carbohydrate content was observed due to malting, with no

apparent change due to toasting.

The data on the degree of starch gelatinisation showed higher

values for the base ingredients - the cereals with green gram showing

91.9 % gelatinisation. Whereas, toasting of oats and soya flour

resulted in a lesser degree of gelatinisation ranging from 56.8 -

58.7%.

Effect of processing on the dietary fibre content is given in

Table 37. Malting of cereals and the green gram reduced the total

dietary fibre and also the insoluble and soluble fractions. Toasting

did not affect the total dietary fibre content including the fractions.

157
Table 36. Effect of processing on the carbohydrate profile of the
food ingredients (g/ lOOg)
Reducing Non- Total Total Total Total Deg of starch
Ingredient sugars reducing sugars starch dietary CHO gelatinisation
sugars flbre
Raw 18.1 15.6 33.7 45.3 7.3 86.3 _
Ragi
Proc. 20.6 17.2 37.8 40.1 5.9 83.8 89.6
Raw 17.6 13.1 30.7 46.9 6.5 84.1 „

Rice
Proc. 19.5 15.6 35.1 40.8 5.2 81.1 82.2
Raw 20.4 17 37.4 38.6 7.5 83.5 -
Barley
Proc. 22.7 18.4 41.1 34.7 4.9 80.7 88.4
Green Raw 11.9 15.6 27.5 39.8 7.4 74.7 -
gram Proc. 16.9 18 34.9 31.8 5.2 71.9 91.1
Raw 13.3 16.2 29.5 40.9 7.5 71.9 „

Oats
Proc. 11.8 15.7 27.5 41.6 1.6 70.7 56.8
Soya Raw 5.4 7.8 13.2 28.5 4.5 46.2 -
flour Proc. 4.8 7.1 11.9 30.4 4.1 46.4 58.7

J 58
Table 37. Effect of processing on the dietary fibre content of the
food ingredients (g/ lOOg)
Insoluble Soluble Total
Ingredient dietary dietary dietary
fibre fibre fibre
Raw 4.2 3.1 7.3
Ragi
Proc. 2.7 3.2 5.9
Raw 3.8 2.7 6.5
Rice
Proc. 2.1 3.1 5.2
Raw 4.6 2.9 7.5
Barley
Proc. 2.1 2.8 4.9
Green Raw 3.3 4.1 7.4
gram Proc. 2.3 2.9 5.2
Raw 4.1 3.4 7.5
Oats
Proc. 3.5 4.1 7.6
Soya Raw 1.6 2.9 4.5
flour Proc. 2.6 1.5 4.1

159
3. Starch fractions of processed food ingredients

Total starch contents and its fractions RDS, SDS and RS are

presented in Table 38. Malted cereals and the green gram had

higher content of both RDS and SDS with decrease in RS content.

Consequently, both the total starch and NSP decreased significantly.

Toasting of oats and soya flour decreased the RDS and SDS fractions

of starch, while RS fraction of oats slightly increased due to toasting.

The RS value of soya flour showed a decrease. Toasting also

increased the total starch content, but decreased the NSP.

Malting of cereals and the green gram increased the RAG

content and thereby the SDI (Table 39). SDI increased by two to

three folds over the unprocessed food ingredients. On toasting while

the RAG decreased slightly, the SDI was maintained similar to that of

raw ingredients.

Table 4 0 shows the ranking of starch fractions as percentage

of total carbohydrate in raw and processed foods. It is obvious that

malting increased the RDS fractions more than the SDS fractions

and decreased the RS which in turn increased the SDI significantly.

However, toasting did not effect any change in the fractions and also

the SDI.

160
Table 38. Effect of processing on the total starch content and its
fractions of the food ingredients (g/ lOOg)
Ingredient RDS SDS RS TS NSP
Ragi Raw 12.6 14.1 18.6 45.3 25.9
Proc. 18.4 16.2 10.1 44.7 16
Rice Raw 9.9 16.6 20.4 46.9 26.9
Proc. 16.8 17.1 11.2 45.1 16.4
Barley Raw 13.5 7.5 17.6 38.6 25.1
Proc. 20.7 9.8 7.4 37.9 12.3
Green Raw 18.7 6.3 12.8 39.8 24.2
gram Proc. 21.3 10 4.1 35.4 9.3
Oats Raw 5.6 13.5 20.8 40.9 28.3
Proc. 5.4 12.5 21.6 39.5 23.2
Soya Raw 3.2 6.6 18.7 28.5 23.2
flour Proc. 2.9 5.9 17.9 26.7 22
RDS- rapidly digestible starch
SDS-slowly digestible starch
RS-resistant starch
TS-total starch
NSP- Non starch polysaccharides = Resistant starch + TDF.

161
Table 39. Effect of processing on the rapidly available glucose
(RAG) and starch digestion index (SDI) of the food ingredients
Ingredient RAG SDI
Ragi Raw 20.7 27.8
Proc. 24.8 41.2
Rice Raw 14.1 21.1
Proc. 18.1 37.3
Barley Raw 22.3 35
Proc. 26.4 54.6
Green Raw 15.9 47
gram Proc. 19.9 60.2
Oats Raw 9.1 13.7
Proc. 8.8 13.7
Soya Raw 8.8 11.2
flour Proc. 8.3 10.9

Rapidly Digestible starch

SDI= X 100
Total starch

162
Table 40. Total sugar, starch, dietary fibre and their fractions as
percentage of total carbohydrates in the processed food
ingredients (g/ lOOg)

Green Soya
Ingredient Ragi Rice Barley Oats
gram flour

Total CHO Raw 86.3 84.1 83.5 74.7 71.9 46.2

TS+TDF+TSU Proc. 88.4 85.4 83.9 75.5 68.6 42.7
Raw 14.6 11.8 16.2 25 7.8 6.9
RDS
CO Proc. 20.8 19.7 24.7 28.2 7.9 6.8
as Raw 16.3 19.7 9 8.4 18.8 14.3
u
SDS
Proc. 18.3 20 11.7 13.2 18.2 13.8
O
X5
u Raw 21.6 24.3 21.1 17.1 30.3 40.5
o RS
Proc. 11.4 13.1 8.8 5.4 31.5 41.9
o Raw 3.6 3.2 3.5 5.5 0.6 6.3
-M

o IDF
Proc. 3.1 2.5 2.5 3 0.7 6.1
<
Raw 4.9 4.5 5.5 4.4 1.5 3.5
SDF
Proc. 3.6 3.6 3.3 3.8 1.6 3.5
Raw 27.8 21.1 35 47 13.7 11.2
S DI
Proc. 41.2 37.3 54.6 60.2 13.7 10.9

163
4. Functional characteristics of raw and processed food

ingredients

Functional characteristics of the raw ingredients are shown in

Table 4 1 . All the functional characteristics viz., bulk density, water

and fat absorption capacities of the food ingredients were almost

similar except for oats and had a higher water absorption capacity

and soya flour showing a higher fat absorption capacity.

Effect of processing the functional properties of the ingredients

is presented in Table 41 and 42. As expected, malting reduced the

bulk density and increased the water and fat absorption capacities.

Whereas toasting did not affect the functional characteristics as the

values remained similar as per the raw ingredients.

C. NUTRIENT COMPOSITION OF FORMULATED ENTERAL FOODS

As per the nutritional need assessment conducted on the

patients under critical care in the hospitals of Mysore, enteral foods

were formulated using the base ingredients viz ragi, rice, green gram

and barley and complimentary ingredients oats and soya flour along

with nutraceuticals specific for each of the disease conditions.

A total of four formulations to meet the nutritional needs of

groups of patients which included general (without any chronic

disease condition) and disease groups - cancer, diabetes and

164
 Table 4 1 . Functional characteristics of the raw ingredients

Item Ragi Rice Barley ^'®®° Oats ^°^^ WMP SMP

^ "^ gram flour
Bulk
0.85 0.72 0.88 0.81 0.78 0.77 0.82 0.88
density
Water
absorption 0.42 0.39 0.46 0.41 0.62 0.48 0.78 0.74
capacity
Fat
absorption 1-21 1-18 1.23 1.26 1.29 1.88 1.10 1.72
capacity

Table 4 2 . Functional characteristics of the processed ingredients

Item Ragi Rice Barley ^'**° Oats l""^^

^ gram flour
Bulk density 0.79 0.68 0.82 0.76 0.77 0.75
Water
absorption 0.51 0.47 0.55 0.53 0.61 0.44
capacity
Fat absorption 1.47 1.39 1.40 1.42 1.28 1.86
capacity

165
HIV/AIDS were prepared as described under an earlier section. The

details of amounts of ingredients added and other preparation

methods are shown in Table 14.

Nutrition composition of the formulated enteral food was

measured in terms of proximate composition and carbohydrate

profile. Proximate composition of the formulated enteral foods is

presented in Table 43. By and large, the proximate composition of

all the enteral foods was similar with slightly content of protein in

case of HSEF and fat content in CSEF respectively. The fibre content

of DSEF was slightly higher than the other foods.

Total ash content of all the four enteral foods had similar

carbohydrate content (by difference) ranging from 57.1 to 59.3%

1. Proximate Composition of the reconstituted enteral foods

The formulated enteral foods were reconstituted in water as

described under methodology. The proximate composition of

reconstituted i.e. ready to use enteral foods are shown in Table 44.

Reconstituted enteral foods had a protein content ranging from

3.8 - 4 . 1 % and the fat content ranging from 3.1 - 3.6% per 100 ml.

The calculated energy content varied from 102 kcal in DSEF to 121

kcal in HSEF. All the reconstituted enteral food had a higher amount

166
 Table 4 3 . Proximate composition of formulated enteral foods
(g/lOOg)*
GEF CSEF DSEF HSEF
Moisture 6.60 7.20 6.10 7.09
Protein 15.42 15.10 15.21 16.52
Fat 12.96 14.11 13.80 13.55
Total ash 2.61 2.52 2.51 2.51
Fibre 3.10 3.05 4.23 3.10
Carbohydrate 59.31 57.12 57.25 58.33
*Values are mean of three replicates
On dry weight basis

Table 44. Proximate composition of reconstituted enteral foods

(g/100ml)
GEF CSEF DSEF HSEF
Energy (kcal) 110 118 102 121
Protein 3.86 3.78 3.80 4.13
Fat 3.19 3.53 3.55 3.14
Total ash 0.65 0.63 0.63 0.63
Fibre 0.78 0.76 1.06 0.78
Carbohydrate 14.08 14.28 14.21 14.33
Protein: Energy
1:28 1:31 1:26 1:29
ratio

167
of protein in terms of P:E ratio. Percent calories contributed from

macronutrients in the reconstituted enteral food is given in Table

45. It could be stated that as per the requirement of patients with

hypercatabolism with or without chronic disease, the enteral food

had higher protein content (-15 - 16%) with moderate fat within 30%

and a carbohydrate content ranging from 54 - 59%.

2. Carbohydrate Profile of the formulated enteral foods

Formulated enteral foods had lower amounts of reducing and

non reducing sugars with a total sugars content ranging from 14.9 to

15.8 % (Table 46). Total starch content ranged between 43% in GEF

to 37.2% in DSEF with a TDF content of 2.8 - 3.7%. While total

carbohydrate content of GEF was 61.1%, in the other three enteral

foods, it ranged from 55.8 to 58.5%, lowest being the DSEF. Among

the four enteral foods, DSEF had a lower degree of starch

gelatinisation (69.1%), the other foods showing 72.1 - 78.7% in GEF

and HSEF respectively. Comparatively, DSEF had higher amount of

dietary fibre, lower amount of starch and sugars along with lower

degree of starch gelatinisation which is desirable for monitoring

glycaemic responses in diabetics. Similarly, HSEF showing higher

degree of starch gelatinisation was desirable for the HIV/AIDS as

these patients are likely to develop gastro intestinal disturbances.

168
Table 4 5 . Percent calories from macronutrients in reconstituted
enteral foods
Item GBF CSEF DSEF HSEF
Carbohyd rate 58.8 54.9 54.1 56.2
Protein 15.0 14.5 15.4 16.2
Fat 26.2 30.6 30.5 27.6

Table 46. Carbohydrate profile of the enteral foods (g/lOOg)

Fraction GEF CSEF DSEF HSEF

Reducing sugars 6.3 6.4 6.2 6.5
Non-reducing 8.9 9.4 8.7 9.0
sugars
Total sugars 15.2 15.8 14.9 15.5
Total starch 43.0 39.9 37.2 39.6
Total Dietary 2.9 2.8 3.7 2.9
Fibre
Total 61.1 58.5 55.8 58.0
carbohydrate
Degree of starch 72.1 74.6 69.1 78.7
gelatinization (%)
*Values are mean of three replicates
On dry weight basis

169
3. Dietary Fibre content of the formulated enteral foods

Dietary fibre profile of the enteral foods is given in Table 47.

Both, the soluble and insoluble fibre content were similar in all the

formulations. The content of SDF was higher than the IDF as it is

desirable for such patients. Among the four enteral foods, the

content of DSEF had highest amount of IDF and SDF which reflected

in higher amounts of TDF.

As dietary fibre particularly the SDF is reported to reduce

hyperglycaemia, it was essential that the enteral food formulated

especially for diabetics contain higher amounts of dietary fibre

particularly the SDF.

D. FUNCTIONAL PROPERTIES OF FORMULATED ENTERAL FOODS

Functional characteristics are important in food formulations,

particularly for enteral foods as they are also used for tube feeding. It

is also desirable to have low bulk density and higher water and fat

absorption capacities. The functional properties of ingredients used

in the formulations reflected in the functional characteristics of the

formulation. The data on the functional properties of the formulated

enteral foods (Table 48) showed that these foods were having low

bulk density and similar water and fat absorption capacities. It was

seen that the water absorption capacities of the enteral formulations

was higher than that reported for individual ingredients earlier

170
 Table 47. Dietary fibre content of the enteral foods (g/lOOg)

Fraction GEF CSEF DSEF HSEF

Insoluble dietary 1.33 1.18 1.65 1.15
fibre
Soluble dietary 1.77 1.87 2.58 1.95
fibre
Total dietary fibre 3.10 3.05 4.23 3.10
*Values are mean of three replicates
On dry weight basis

Table 4 8 . Functional properties of the formulated enteral foods

GEF CSEF DSEF HSEF
Bulk density 0.62 0.63 0.61 0.64
Water absorption 0.68 0.70 0.64 0.66
capacity
Fat absorption capacity 1.11 1.18 1.09 1.21

171
(Tables 4 1 and 42) and the fat absorption capacities was much

lower than that of the ingredients. Formulation ensured that these

foods were having satisfactory water and fat absorption capacities.

This was also desirable for easy flow when used for tube feeding.

E. NUTRITIONAL QUALITY OF THE ENTERAL FOODS

An in vitro evaluation of nutritional quality of the formulated

enteral foods using protein quality {in vitro) and carbohydrate

bioavailability (in vitro) in terms of nutritionally important starch

fractions as indicators was carried out.

1. In Vitro Ehraluation of Protein Quality

Since high protein diets are recommended in any

hypercatabolic illness with or without co-morbidities such as

diabetes, enteral foods were formulated to contain high amounts of

protein ranging from 15.1 to 16.5% per lOOg dry powder (Table 43).

Amino acid profile of the formulated enteral foods is presented in

Table 49. Amino acid profile of GEF is comparable to the reference

egg protein in most of the amino acid content. Since two of the amino

acids were supplemented in the disease-specific enteral foods, their

contents were much higher than either egg or GEF. Essential amino

acid composition of the formulated enteral foods is shown in Table

50. As compared to the essential amino acid profile egg protein, all

the enteral foods had slightly higher amounts of essential amino

172
 Table 4 9 . Amino acid profile of the formulated enteral foods
Amino acid Egg* GEF CSEF DSEF HSEF
Alanine 5.49 5.31 4.43 3.87 3.84
Argenine 4.54 5.48 15.13 15.13 15.74
Aspartic acid 6.09 9.44 10.18 10.23 9.01
Cysteine 1.88 1.20 1.04 1.05 1.12
Glutamine 10.89 20.89 21.65 21.45 21.67
Glycine 2.89 3.12 3.87 3.29 3.26
Histidine 1.67 2.61 2.24 2.18 2.12
Isoleucine 5.00 5.38 5.79 5.39 5.78
Leucine 6.80 9.5 9.44 8.73 9.01
Lysine 4.64 6.71 7.24 6.97 7.18
Methionine 3.01 3.18 3.21 2.92 2.95
Phenylalanine 4.94 4.92 4.89 4.71 4.91
Proline 2.92 7.81 7.99 7.88 7.66
Serine 6.07 1.28 1.31 1.13 1.11
Threonine 3.41 3.61 3.87 3.61 3.42
Tryptophan 1.18 1.32 1.58 1.64 1.57
Tyrosine 3.21 1.73 1.91 1.95 1.26
Valine 6.02 5.51 6.7 6.48 5.93
^Source: FAO (217)

173
 Table 50. Essential amino acid composition of the formulated
enteral foods

Amino acid Egg* GEF CSEF DSEF HSEF

Isoleucine 5.00 5.38 5.79 5.79 5.78
Leucine 6.80 8.6 9.44 8.73 9.01
Lysine 4.64 6.71 7.24 6.97 7.18
Methionine +
4.89 4.38 4.25 3.97 4.07
Cysteine
Phenylalanine +
7.15 6.65 6.8 6.66 6.17
Tyrosine
Threonine 3.41 3.61 3.87 3.61 3.42
Tryptophan 1.18 1.32 1.58 1.64 1.57
Valine 6.02 5.51 6.7 6.48 5.93
Total EAA 40.09 42.16 45.67 43.85 43.13
^Source: FAO (217)

174
acids except for phenylalamine + tyrosine which was slightly less

than that of the egg protein. In case of GEF, the content of valine was

slightly lower than that contained in egg protein. It is reported that

available lysine is increased due to heat processing. Though the

available lysine content is not measured, it is likely that there may

be increase in its availability due to the processing treatments of

used for the formulations.

The chemical score (FAO, 1970) for individual amino acids and

the sequence of limits amino acids in the formulated enteral foods

are presented in Table 5 1 . Chemical score of the enteral foods

ranged from 87 in CESF to 80 for GEF. It is observed from the table

that methione and cysteine which are considered together for the

chemical score are the first limiting amino acids in all the enteral

foods. While the second limiting amino acid was found to be

phenylalanine and tyrosine for the disease specific enteral foods, it

was found to be valine in case of GEF. For the GEF, phenylalanine +

tyrosine combined became the third limiting amino acid. The

sequence of limiting amino acids was constructed based on an amino

acid score below 100.

Protein quality of the formulated enteral food in terms of

chemical score, essential amino acid index and the predicted

biological value are given in Table 52. All the formulated enteral

175
 Table 5 1 . Chemical scores and sequence of limiting amino acids
in
the formulated enteral foods

Amino acid GEF CSEF DSEF HSEF

Isoleucine 108 116 116 116
Leucine 126 139 128 133
Lysine 144 156 150 155
Methionine +
80 87 81 83
Cysteine
Phenylalanine
94 95 93 86
+ Tyrosine
Threonine 106 113 106 100
Tryptophan 110 134 139 133
Valine 91 111 108 99
Chemical 87
80 81 83
score
1
Methionine + Methionine + Methionine + Methionine +
Sequence Cysteine Cysteine Cysteine Cysteine
of limiting Phenylalanine Phenylalanine
II Valine Phenylalanine
amino + Tyrosine + Tyrosine + Tyrosine
acids Phenylalanine
+ Tyrosine
III

Table 5 2 . Protein quality of the formulated enteral foods

GEF CSEF DSEF HSEF
Chemical score 80 87 81 83
Essential amino 88 93 85 85
acid index
Biological value 83 89 82 80
(Predicted)

176
foods showed a higher essential amino acid index compared to the

predicted biological value and the chemical score. The predicted

biological score was slightly higher than the chemical score in three

of the enteral foods, GEF, CSEF, DSEF while being slightly lower in

case of HSEF.

By and large, as per indications of protein quality (in vitro), the

protein quality of the formulated enteral foods could be considered as

high biological value protein. It is to be noted that if milk is used for

reconstitution of the enteral foods instead of water, the protein

quantity can be increased further with an enhanced quality.

2. Starch fractions of the formulated enteral food

Carbohydrate profile of the formulated enteral foods is

presented in Table 4 6 in an earlier section which showed that the

total carbohydrate content of these foods ranged from 55.8 to 61.1%

with a total starch content ranging from 37.2 to 43%. The foods also

had a low amount of dietary fibre with DSEF having the highest

amount (3.7%). The reducing sugar and total sugar content was

found to be within 25% in these foods. However, in health foods such

as these, it is essential to determine the starch and fibre fractions

which are considered as indicators of carbohydrate bioavailability [in

vitro) and thus considered nutritionally important.

177
Table 5 3 shows the nutritionally important carbohydrate fractions.

The carbohydrate fractions also include resistant starch besides

fractions of starch expressed in terms of rapidly digestible and slowly

digestible starch. In addition, it also contains dietary fibre as IDF

and SDF fractions. Since resistant starch is not hydrolysed by a-

amylase, it can be considered as part of total dietary fibre. All the

enteral foods contained almost similar amounts of RDS and SDS

except for DSEF, which had RDS in amounts much lower than the

other foods. A slight variation was also observed in SDS amounts as

it was higher in GEF and lower in HSEF comparatively, RAG content

of the foods is presented in Table 54. The RAG value represents the

amount of glucose that can be expected to be rapidly available for

absorption after a meal. The highest amount (38.6%) was found to be

present in GEF and the lowest (31,1%) in DSEF which was desirable

in the diets for the diabetics. The other two foods had a RAG content

of 36.9% (CSEF) and 35.7% (HSEF) respectively. Starch Digestion

Index (SDI) which is a measure of relative rate of starch digestion is

also shown in Tables 5 4 and 55. SDI values were found to be very

low ranging from 30.5% in DSEF to 37.8% in CSEF and HSEF. GEF

had a SDI of 35.3%. DSEF had a much lower SDI than the other

formulation.

From the indicators it could be stated that carbohydrate

availability {in vitro) may be expected to have a slowly and steadily

178
 Table 5 3 . Total starch content and its fractions in the enteral
foods (g/ lOOg)*

Fraction GEF CSEF DSEF HSEF

RDS 15.2 15.1 11.36 14.9
SDS 16.22 14.47 13.8 13.82
RS 11.6 10.4 12.1 10.9
TS 43.02 39.97 37.26 39.62
NSP 14.7 13.5 16.3 14.0
*Values are mean of three replicates
On dry weight basis
RDS- rapidly digestible starch
SDS-slowly digestible starch
RS-resistant starch
TS-total starch
NSP- Non starch polysaccharides = resistant starch + TDF.

Table 54. Rapidly available glucose (RAG) and starch digestion

index (SDI) of the enteral foods
RAG SDI
GEF 38.6 35.33
CSEF 36.9 37.78
DSEF 31.1 30.49
HSEF 35.7 37.61

Rapidly Digestible starch

SDI= X100
Total starch

179
 Table 55. Nutritionally important carbohydrate fractions as
percentage of total carbohydrates in the enteral foods
(g/lOOg)

Enteral '^otal CHO As % of total carbohydrates

food SDI
TS+TDF+TSU RDS SDS RS IDF SDF
GEF 61.1 24.8 26.5 18.9 2.2 2.9 35.3
CSEF 58.5 25.8 24.7 17.7 2.0 3.2 37.8
DSEF 55.8 20.3 24.7 21.6 3.0 4.6 30.5
HSEF 58.0 25.6 23.8 18.7 2.0 3.4 37.6
*Values are mean of three replicates
On dry weight basis

180
releasing characteristics which is desirable for patients under critical

care.

F. ACCEPTABILITY AND STORAGE QUALITY OF FORMULATED

ENTERAL FOODS
The data on the acceptability of the formulated enteral foods as

indicated by their sensory evaluation followed by safety of these

foods as indicated by the microbiological analysis are presented here.

1. Sensory evaluation of the formulated enteral foods

Sensory scores for the enteral foods are presented in Table 56.

The sensory scores for all the quality parameters ranged between 8.1

for consistency to 8.9 for colour. The sensory scores of all the four

formulated foods were found to be similar scoring above 8 for all the

quality attributes including overall acceptability. Hence, they were

found to be highly acceptable. The differences in quality attributes

between the types of enteral foods were not significant.

Effect of storage on the sensory quality of the four enteral food

formulations is shown in Table 57. It was seen that scores for each

of the sensory attributes reduced with increased storage period. At

the end of 30 days, the decrease in the sensory scores was not

significant. Though the decrease in the sensory scores were

significant at the end of 60 days as compared to the fresh sample,

still the products were acceptable with sensory scores ranging

181
 Table 56. Sensory quality of the enteral foods
Quality
GEF CSEF DSEF HSEF
parameter

Colour 8.8^ 8.8« 8.7a 8.9a

Aroma 8.8a 8.8a 8.9a 8.8a

Taste 8.2b 8.4a 8.2a 8.3a

Consistency 8.1b 8.3b 8.1b 8.4a

Overall
8.3a 8.5a 8.6a 8.4a
acceptability
Any two means in different columns carrying different superscripts
a, b, c . differ significantly (p<0.05)
Limits of quality mean scores:
Fair - 5.6-6.5
Good - 6.6-7.5
Very good - 7.6-8.5
Excellent - 8.6-10.0

182
 Table 57. Effect of storage on the sensory quality of enteral
foods

GEF CSEF DSEF HSEF

Quality
parameter Days
0 30 60 0 30 60 0 30 60 0 30 60
Colour 8.8a 8.4a 7.9b 8.8^ 8.3^ 7.8 8.7a 8.2a 7.7c 8.9a 8.5a 7.9b
Aroma 8.8a 7.9a 7.8b 8.8a 7.8^ 7.7= 8.9a 7.7b 7.6c 8.8a 7.7b 7.7b
Taste 8.2a 8.0a 7.8b 8.4a 8.1a 7.8= 8.2a 8.1a 7.8c 8.3a 8.0a 7.7b
Consistency 8.1a 7.8a 7.7^ 8.3a 7.9^ 7.5<= 8.1a 7.7a 7.6c 8.4* 7.9a 7.6^

Overall g ^^ g ^^ ^ g^ g^^ g ^^^ ^^^ g^^ g 2^ y g^ 34^ g Q^ 77b

acceptability
Any two means in different columns carrying different superscripts a, b, c .
differ significantly (psO.05)
Limits of quality mean scores:
Fair - 5.6-6.5
Good - 6.6-7.5
Very good - 7.6-8.5
Excellent - 8.6-10.0

183
between 7.6 for consistency to 7.9 for colour. The overall

acceptability scores ranged from7.7 to 7.8 without any difference

between the samples.

2. Microbiological safety of the formulated enteral foods

Enteral formulations as evaluated by their microbial quality

were found to be having microbial count in acceptable limits (Table

58). Food safety of the enteral formulations accessed over a period of

60 days showed a gradual increase in the presence of microbes and

in the total counts, though not significant with no differences

between the four formulations. Thus, changes in the microbiological

scores were found to be minimum without affecting the safety for

human consumption.

3. Moisture, Peroxide value and Free fatty acids in the stored

samples

The data on the peroxide value and free fatty acid content

which showed an increase in all the four samples stored up to 30

days, increased further as the period of storage was extended to 60

days (Figure 17). It has been observed that milled food ingredients

generally show an increase in peroxide value and free fatty acids on

storage. However, these changes did not significantly affect the

quality as increase in these parameters is expected when foods are

stored at room temperature.

184
 Table 58. Effect of storage on the microbiological quality of
enteral foods (logio cfu/g)

GBF CSEF DSEF HSEF

Quality T
parameter ^^^
0 30 60 0 30 60 0 30 60 O 30 60

Standard ^ ^ ^ ^ ^^ g 2b 5 5a 7.4a 8.3b 6.6^ 7.2^ 8.3^ 6.5« 7.3^ 8.3^

plate count

Yeast and ^.la 2.3a 2.6^ 2.2^ 2.4^ 2.5b 2.0^ 2.3^ 2.5" 2.2^ 2.4^ 2.6^
mould
Conforms 1.1^ 1.2^ 1.5^ 1.1a 1.3a 1.6a i.2a 1.3a 1.6a 1.2a 1.3a 1.6a

Mesophihc 2 ga 3.0a 3.4b 2.7a 3.0a 3.5b 2.6a 3.0a 3.4b 3.4a 3.1a 3.5a
Spores
Any two means in different columns canying different superscripts a, b, c .
differ significantly (p<0.05)

185
 Days

Figure 17. Changes in moisture, Peroxide value and free fatty

acid content of formulated enteral foods on storage

186
Discussion

The reported studies have indicated that suitable good quality

and economical enteral preparations are lacking though a number of

commercial formulas are available. In India, a majority of the

patients do not opt for such formulations as they are expensive.

Hence, the patients are forced to depend on hospital blenderised

foods which are often nutritionally inadequate and unsafe.

Hence, the current trend in food formulations is to utilise

commonly used food ingredients which are easily available and cost-

effective. It h a s been established that in treating malnutrition, food-

based approach is reported to be the best (104). Though nutrient

supplements (in the form of tablets and tonics) show immediate

improvement, the earliest change over to the diet- or food-based

approach is known to be beneficial in the long term. Hence, in the

present study, for the enteral food formulations, commonly used

cereals and pulses were used. To make it beneficial to the patients

with diseases, condition-specific ingredients and nutraceuticals have

also been added.

The data on the proximate composition and carbohydrate

profile were similar to the values reported in the food composition

tables. However, these ingredients need to be processed for designing

specific food preparations suitable to patients. Among the processing

187
treatments, germination and malting have been reported to be

beneficial for the preparation of enteral foods. It has been reported

that during germination, desirable nutritional changes occur, which

is more beneficial for patients. As such, the data indicated that

although germinated and malted cereals and pulse showed marginal

changes in proximate composition as compared to raw grains,

functionally, it was beneficial as the processing reduced the bulk

density and improved the water and fat absorption capacities.

It has been shown that these functional changes increase the

nutritional density, thus improving the nutritional quality. The

proximate composition of the formulated enteral foods reflected the

composition of the food ingredients used in their preparation. The

composition of the reconstituted enteral foods was comparable to the

enteral foods available commercially.

The results also indicated that the formulated enteral foods

were highly acceptable and could be stored for u p to 2 months

without deterioration in microbial quality and sensory parameters.

It is established that patients under critical care require not

only high-protein diets, but the proteins should also be of high

biological value (HBV proteins). In vitro indices - chemical score used

in the study indicated that the food formulations were of HBV and

188
comparable to that of egg protein (125). The data on the

carbohydrate availability (in vitro) showed that the food formulations

had equal amounts of rapidly digestible starch (RDS) and slowly

digestible starch (SDS) with low starch digestion index (SDI). It was

possible to successfully design and formulate an enteral food - DSEF

meant for diabetics with the lowest SDI and high amounts of fibre. It

has been shown that SDI and the glycaemic index (GI) of foods are

highly correlated (186). Low GI foods have been reported to have

advantages in improving metabolic control in diabetics, besides

lowering serum lipids and blood pressure. Since many of the patients

reported having hypertension, the formulated are expected to be

highly beneficial for such patients. Even in respect to cancer-specific

enteral food and HIV/AIDS the ingredients were added based on

reported benefits for patients, thus, the food formations prepared out

of locally available ingredients having condition-specific nutrients

can be recommended for patients under critical care.

III. E F F E C T O F FEEDING FORMULATED FOODS IN

GENERAL AND SPECIFIC D I S E A S E GROUP PATIENTS
U N D E R CRITICAL CARE

Enteral foods formulated for different groups of patients,

general and disease-specific, were clinically tested using patients

admitted to the critical care units in selected hospitals in Mysore and

also outside. The details of patients drawn for the study are shown in

189
Table 15 in an earlier section. A total of 66 patients were selected

based on their conditions and also having specific disease conditions

viz., cancer, Type 2 diabetes and HIV/AIDS. The formulated enteral

feeds were fed to the selected patients under each category replacing

the hospital diet. The efficacy of the food formulations were tested by

comparing the outcome measures in a control group maintained

under the same conditions, but following the hospital dietary

regimen. At the start of the clinical trial, background information and

details of the nutritional support for the patients was collected.

A. BACKGROUND INFORMATION OF THE SELECTED PATIENTS

The age group of the selected patients and cause of admission

to the hospital along with their total stay at the intensive care unit

(ICU) is presented in Table 60. Patients were in the age group of I8-

60 years with more than 40% of them in falling in the age bracket of

30-50 years. The cause of admission included cardiac diseases

including hypertension, cancer, diabetes and HIV/ADIS. The total

number of days of the patients' stay at the ICU ranged from 24h to

14 days. Generally, patients requiring close monitoring were kept in

the ICU and on improvement in their conditions were shifted to the

wards. A majority of the patients (54.5%) had stayed in the ICU only

for 1-3 days before being shifted. It was observed that the patients

190
Table 60. Age group and cause of admission of selected patients
[No. (%)]
Men Women Total
Age group
10 8 18
18-30 (15.2) (12.1) (27.3)
10 9 19
30-40 (15.2) (13.6) (28.8)
11 12 23
40-50 (16.7) (18.2) (34.8)
4 2 6
50-60 (6.1) (3.0) (9.1)
Cause of admission
3 2 5
Hypertension
(4.5) (3.0) (7.6)
4 2 6
CVD (6.1) (3.0) (9.1)
4 5 9
Surgery (6.1) (7.6) (13.6)
11 9 20
Cancer
(16.7) (13.6) (30.3)
10 10 20
Diabetes (15.2) (15.2) (30.3)
3 3 6
HIV/AIDS (4.5) (4.5) (9.1)
No. of days in ICU
19 17 36
1-3
(28.8) (25.8) (54.5)
9 10 19
4-7 (13.6) (15.2) (28.8)
4 2 6
8-10 (6.1) (3.0) (9.1)
3 2 5
11-14 (4.5) (3.0) (7.6)

191
who underwent surgeries were found to be staying at the ICU for a

longer duration i.e. maximum 14 days.

Environmental characteristics of the selected patients are

presented in Table 6 1 . Fifty nine percent of the patients were having

a nuclear family and more than 50% of them had an education level

up to matriculation/Pre-university with a monthly income ranging

between Rs. 5000-10,000. while 19.7% of them had a monthly

income above Rs. 10,000, 12% were having a very low income of less

than Rs. 2000 per month. Only 65% of the patients responded

having habits like chewing tobacco (34.8%), alcohol consumption

(15%) followed by smoking (9%).

Dietary pattern of these patients indicated the pattern to be

similar to that followed in the specific area-Mysore/Gujarat, being in

the habit of consuming 2-3 main meals a day. Meal and menu

pattern that was generally being followed is given in Table 62.

The frequency of food consumption (Table 63) showed wheat

and rice to be the main food items followed by pulses and milk 86

milk products. Daily consumption of vegetables and fruits was found

to be low. Mean food intake of the selected patients retrospectively

assessed and compared to the desirable dietary pattern (DDP) based

on RDA for reference man and woman is presented in Table 64. It

could be seen that except for cereals, the consumption of all other

192
Table 6 1 . Environmental characteristics of selected patients
No. (%)
Men Women Total
Type of family
33 26 59
Nuclear
(50.0) (39.4) (89.4)
2 5 7
Joint
(3.0) (7.6) (10.6)
Educational s t a t u s
4 8 12
No formal education
(6.1) (12.1) (18.2)
8 10 18
Matriculation
(12.1) (15.2) (27.3)
11 6 17
Pre-University (16.7) (9.1) (25.8)
9 4 13
Graduation (13.6) (6.1) (19.7)
Post-graduation 6
(7.6) (1.5) (9.1)
Monthly i n c o m e
3 5 8
<2000
(4.5) (7.6) (12.1)
4 8 12
2000-5000
(6.1) (12.1) (18.2)
21 12 33
5000-10,000 (31.8) (18.2) (50.0)
10 03 13
> 10,000 (15.2) (4.5) (19.7)
Health related habits
5 1 6
Smoking (7.6) (1.5) (9.1)
14 9 23
Chewing tobacco (21.2) (13.6) (34.8)
Drinking/Alcoholism 12 15
(18.2) (4.5) (22.7)

193
 Table 6 2 . Meal pattern of the selected patients

Time Meal pattern Preparation

6:00-7:00 AM Coffee/Tea
7:30-8:30 AM Breakfast* Chapathi, paratha, puri, sabzi, idli,
dosa, chutney, sambhar, playa, lime
rice, upma
12:30-2:00 PM Lunch Chapathi, rice, dal, vegetable curry,
buttermilk
4:00-5:00 PM Coffee, tea, badam milk
7:30-9:30 PM Dinner Rice, chapathi, dal, sambhar,
vegetables, curry, fruit
Any one cereal preparation accompanied with a side dish

194
 Table 6 3 . Frequency of food consumption of the selected
patients No. (%)
Food i t e m Daily Twice/ Weekly Fortnightly Monthly Never
week
Cereals 66 - - - - -
Ragi - - - 20 06 40
(30.3) (9.1) (60.6)
Wheat 34 26 6
(51.5) (39.4) (9.1)
Rice 28 20 18
(42.4) (30.3) (27.3
Pulses 60 6
(90.9) (9.1)
Green leafy 33 7 8 10 05 03
veg (50.0) (10.6) (12.1) (15.2) (7.6) (4.5)
Roots 85 39 12 8 7
tubers (59.1) (18.2) (12.1) (10.6)
Other veg 54 12
(81.8) (18.2)
Fruits 45 10 3 2 06
(68.2) (15.2) (4.5) (3.0) (9.1)
Milk 86 milk 53 10 3
products (80.3) (15.2) (4.5)
Meat 6 22 7 31
(9.1) (33.3) (10.6) (47.0)
Chicken 03 17
(4.5) (25.8)
Mutton 9
(13.6)
Others 01
(1.5)
Eggs 08 14 18 26
(12.1) (21.2) (27.3) (39.4)
Fats 66
(100.0)
Ghee 31 35
(47.0) (53.0
Coconut oil 06 60
(9.1) (90.9)
Other oil 66
(100.0)
Sugar/Jaggery 60 - - - - 06
(90.9) (9.1)

195
 Table 64. Mean dietary food intake of selected patients

Food item Men Women

(g/ml) Intake DDP* Intake DDP*
Cereals 340 ± 25 360 310 ± 4 0 340
Pulses 48+ 15 60 40 ± 15 50
Green leafy vegetables 45 ± 2 0 85 42 ± 2 0 80
Roots 8B tubers 38 ± 2 5 50 33 ± 15 45
Other vegetables 37 ± 15 50 36 ± 15 45
Fruits 20 ± 10 35 20 ± 10 30
Milk 145 ± 30 185 128 ± 3 0 160
Meat 32 ± 15 40 28 ± 15 35
Fats and oils 21 ± 15 30 22 ± 10 25
Sugar/Jaggeiy 20 ± 10 25 20 ± 10 25
•'DDP - Desirable dietary pattern computed based on RDA of ICMR

196
food items was much lower than the DDP. The mean energy and

nutrient intake of the patients (Table 65) reflected the food intake of

the patients showing that except for energy, all other nutrients were

significantly lower that the RDI. Between the groups, the nutrient

intake of women showed a greater deficit when compared to men. It

is possible that micronutrient deficiency over a long period of time

could have resulted in malnutrition and contributed to the disease

process.

Percentage of nutrient adequacy as compared to the

recommended allowances (156) is presented in Table 66 and clearly

shows that higher percentages of patients were showing deficit below

70%. Index of nutritional quality which takes into account the

nutrient density per 1000 kcal (Figure 18) also showed a deficit

particularly, of the micronutrients in these patients. Thus, it could

be stated that these patients were consuming a deficient diet

contributing to malnutrition over a long period of time. Dietary

deficits also reflected in the somatic status and biochemical

parameters of these patients.

The somatic status of the selected patients assessed using

anthropometric/body size measurements are presented in Table 67.

the percentile classification of the patients by BMI (indicating energy

status), MUAC/MUAMC (protein status indicator) and SFT (fat status

197
 Table 65. Mean energy and nutrient intake of selected patients

Men Women
Nutrient
Mean RDI* Mean RDI
Energy (Kcal) 1920 ± 150 2135 + 77 1735 ± 165 19851112
Protein (g) 57.3 ±11.2 63.9±13.2 42 1 1 1 . 5 51.6115.6
Fat** (g) 34.2 1 12.3 - 2 8 1 11.0 -

Carbohydrate* (g) 345.5 142.8 - 301.5143.1 -

Calcium (mg) 262.31120.0 400 219.51106.4 400

Iron(mg) 21.4117.1 28 2 0 . 8 1 14.7 30
Retinol(^g) 391.51115.5 600 320.51115.4 600
Ascorbic acid (mg) 32.7 l 14.2 40 28.6 1 12.8 40
Thiamine (mg) 1.0 l 0.5 1.2 1 0 . 4 0.8 1 0.4 1.1 ±0.2
Riboflavin (mg) 1.110.7 1.3 1 0 . 5 0.9 1 0.3 1.2 1 0 . 4
Niacin (mg) 12 1 6.4 1517.8 11 1 12.3 13 1 6.6
*RDI - Values are mean of RDI computed using ICMR
recommendations for each person based on desirable body weight
** No RDA. The suggested intake is Fat >30g and Carbohydrates >150g
Any two means in different columns carrying different superscripts a, b, c .
differ significantly (p^O.05)

198
 Table 66. Percentage adequacy of nutrients consumed
by the subjects
No. (%)
Percentage adequacy
Nutrient
<50 51-70 71-90 >91
5 15 41 5
Energy
(7.6) (22.7 I (62.1) (7.6)
5 39 18 4
Protein
(7.6) (59.1 (27.3) (6.1)
7 24 28 7
Fat
(10.6) (36.4 I (42.4) (10.6)
17 36 12 1
Calcium
(25.8) (54.5 1 (18.2) (1.5)
25 27 7 7
Iron
(37.9) (40.9 1 (10.6) (10.6)
26 32 4 4
Retinol
(39.4) (48.5 I (6.1) (6.1)
28 19 16 3
Thiamine
(42.4) (28.8 I (24.2) (4.5)
24 28 11 3
Riboflavin
(36.4) (42.4 1 (16.7) (4.5)
23 26 15 2
Niacin
(34.8) (39.4 I (22.7) (3.0)
14 16 29 7
Ascorbic acid
(21.2) (24.2 I (43.9) (10.6)

199
 A N D ARCHIVAL SEC^
SECTION

standard/
1 0 0 0 Kcal Nutrient

J Ascorbic acid |0.8

J Niacin 0.4
<D

Ol
J Riboflavin |0.6
o
Ol
J Thiamine |0.6
o
o
o Retinol |0.3

0.3
1 E
s
5 Calcium |0.6
9
S Protein
1 |0.8

0.2 0.4 0.6 0.8 1.2

Nutrients as proportion of energy

Figure 18. Nutrient profile of the patients based on recommend

allowance/ lOOOKcal - Index of Nutritional Quality

200
Table 67. Mean anthropometric measurements and indices of
patients
Measurement/indices Men Women
(n=58) (n=42)
Height (cm) 165.2 ± 8.3 154.3 ± 12.4
Weight (kg) 62.3+ 11.6 51.7 ± 13.0
Body Mass Index 23.6 ± 9 . 8 22.8 ± 8 . 6
MUAC (cm) 31.6+ 13.9 33.4 ± 14.7
Skin fold thickness (mm) 19.6 ± 3 . 6 21.5 ± 4 . 8
MUAMC (cm) 24.6 ± 11.4 21.3 ± 9 . 8

201
indicator) are presented in Table 68. It could be seen that 50% of the

patients showed a BMI of less than 18.5 indicating chronic

malnutrition. An almost equal number of men and women (25.8 and

24.2 % respectively) were found to be malnourished by these criteria.

Similarly, an equal number of men and women were also found to be

in the normal range. A small percent of patients were found to be

overweight (15.2%) and obese (4.5%). Percentile classification of the

patients by MUAC and MUAMC, indicators of protein status showed

that more than 60% of the patients had low protein status ranging

between 70% to lower than 60% of normal. Fat status of these

patients by the criteria of SFT is also presented in Table 68. Here,

higher number of patients (39.4%) showed a fat status ranging

between 61-70% of normal. It was observed that an almost equal

number of men and women showed deficient fat and protein status.

However, it should be noted here that except one patient who showed

normal MUAMC status, no other patient exhibited normal protein or

fat status with all of them showing varying degrees of

malnourishment. Thus, a majority of patients hospitalised for

various conditions showed varying degrees of protein-energy

malnutrition at the time of admission itself.

Discussion

The results of the present study are indicative of the fact that

the patients under critical care are malnourished. The presence of

protein - energy malnutrition which was observed among the

202
Table 68. Percentile Classification of patients by somatic status
[No. (%)]
BMI Men Women Total
<18.5 17 16 33
(25.8) (24.2) (50.0)
18.5-24.9 12 12 24
(18.2) (18.2) (36.4)
25-29.9 5 5 10
(7.6) (7.6) (15.2)
30-34.9 1 2 3
(1.5) (3.0) (4.5)
MUAC
<60 10 11 21
(15.2) (16.7) (31.8)
61-70 11 10 21
(16.7) (15.2) (31.8)
71-80 12 11 23
(18.2) (16.7) (34.8)
81-90 2 3 5
(3.0) (4.5) (7.6)
SFT )
<60 13 10 23
(19.7) (15.2) (34.8)
61-70 10 16 26
(15.2) (24.2) (39.4)
71-80 9 8 17
(13.6) (12.1) (25.8)
81-90 3 1 4
(4.5) (1.5) (6.1)
MUAMC
<60 12 10 22
(18.2) (15.2) (33.3)
61-70 9 14 23
(13.6) (21.2) (34.8)
71-80 10 8 18
(15.2) (12.1) (27.3)
81-90 4 2 6
(6.1) (3.0) (9.1)
>90 1 1
- (1.5) (1.5)

203
patients in the preliminary study was evident among these patients

also. It was seen from the retrospective dietary intakes that their

diets were predominantly cereals based with low amounts of

protective foods. Thus it can be assumed that these patients were

subsisting on a deficient diet. It is possible that malnutrition per se

may increase the risk of developing chronic diseases such as cancer,

diabetes, cardiac diseases and other co-morbidities. Moreover,

malnutrition in a hospitalised patient can have serious consequences

leading to immunodeficiency and frequent infections. In this

condition of infection/disease and semi-starvation in hospitalised

patients, visceral protein apparently becomes a major external

contributor. (The low serum albumin and Hb levels seen in these

patients confirm that the visceral protein stores were indeed the

major contributors of energy sources.) Besides in the patients who

are semi-starved, energy needs of the body are also met by the

skeleton muscle protein and fat. The state of each can be

independently assessed by anthropometry and biochemical

measurements.

While anthropometry - SFT, MUAC and MUAMC indicate the

fat stores and muscle protein stores respectively, the visceral protein

status can be measured by the levels of circulating proteins such as

serum albumin levels. In the present study, it was observed that

more number of patients were showing chronic energy deficiency

204
besides low fat and protein status. Serum albumin and haemoglobin

levels were also low. Hence, every effort must be made to provide

nutritional support to meet the identified nutritional needs of the

patients. Thus, nutritional support should be an integral component

of general care for critically ill patients. It is now possible to provide

appropriate nutritional support through enteral or parenteral

nutrition. Research studies have proved that adequate nutritional

support having disease-specific supplements promotes weight gain,

improves muscle and visceral protein function besides affording

better control of the disease. This would also decrease the

complication rate and duration of hospital stay with decrease in the

treatment costs.

The outcome of feeding the formulated enteral foods in the four

groups of patients is presented below using somatic status and

selected biochemical parameters.

B. EFFECT OF FEEDING THE FORMULATED ENTERAL FOOD -

GEF TO THE GENERAL CATEGORY PATIENTS UNDER CRITICAL
CARE.
It was observed that most of the patients under this category

had been admitted to the hospital for surgery. Initially as they were

admitted, they were put on oral feeding and subsequently they were

started on enteral feeding. Type and volume of the oral/enteral

feeding given to the patients under general category is shown in

205
Table 69. As seen, the total volume as well as the volume per feed

given to the patients was lower in the experimental group than the

control group. This indicates the higher nutrient density of the

formulated enteral food than that of the hospital diet which required

more quantity for an Isocaloric diet. Feeding regimen of the selected

patients under general category is given in Table 70. In case of

control group, the feeding regimen included individual foods like

milk, eggs, fruit juices, soups, coconut water etc. in addition, a

commercial enteral food - Resource''^^ was also being given for one

feed everyday. Honey and butter were added to the regimen to

increase the energy content to match the energy content of the

formulated GEF being given to the experimental group of patients.

Mean energy and nutrient intake of Group I patients is presented in

Table 71. Since the diets were made Isocaloric, the energy content of

the diets were almost similar for the experimental and control

groups. The nutrient intake of the patients on the experimental and

control groups were comparable being almost similar.

Effect of GEF on the anthropometric measurements and

indices of Group I patients is shown in Table 72. It was noticed that

there was a positive increase in the measurements in experimental

as well as control groups. However, the increases were significantly

higher in the experimental group compared to the control group.

206
Table 69. Details of nutritional support of Group I GEF patients

No. of patients
Experimental Control
(n=9) (n=ll)
Oral feeding (Initial) 9 10
Enteral feeding
Pre-operative 9 11
Peri-operative 9 10
Post-operative 9 11
Mean
No. of feeds 5-9 6-10
Volume per feed 240 ± 25 ml 270 ± 30 ml
210-320 240 - 350
Total volume of feeds 1980 ± 50 ml 2460 ± 55 ml
1250 - 2270 1470 - 2800

207
Table 70. Feeding regimen (Isocaloric) of Group I GEF patients
Control Experimental
Time Foods Quantity Time Foods Quantity

6:30AM Milk + Egg + 240 8;00AM 270

GEF
Butter
8:30AM Resource''''^ + 240 11:00AM 210
GEF
honey
10:30AM Sweet lime 240 1:00PM 320
GEF
juice
Dal + Veg
12:30PM soup + Rice 350 4:00PM GEF 210
broth
3:30PM Coconut water 240 6:00PM GEF 210
5:00PM Milk + butter 240 8:00PM GEF 320
7:00PM Groundnut 240 10:00PM 210
GEF
milk + honey
Dal + Soya +
9:00PM rice/ragi 350
broth
11:00PM Milk + butter 240
Total amount/day 2380 1750

208
 Table 7 1 . Mean energy and nutrient intake of
Group I GEF patients

Nutrient Men Women

Experimental Control Ebcperimental Control

Energy (Kcal) 1930a ± 45.2 1925a ± 35.5 1715b ± 150.1 1725b ±155.4

Protein (g) 59.2a ± 11.3 57.3a ± 10.2 48b ± 11.8 46b ± 12.3

Fat (g) 33.1a± 12.4 34.4a ± 14.1 27b ± 11.9 28b ± 12.7

Carbohydrate (g) 325.5a ± 34.8 305.5a ±35.0 290.0b ± 44.5 285.5b ± 40.0

Calcium (mg) 380.5a ± 110.2 375.0a±99.5 390.5b ± 9 5 . 5 370.5b ± 95.4

Iron (mg) 30.7a ± 10.2 23.4a ± 12.1 30b ± 19.7 24b ± 11.3

Retinol (|ug) 565.5a ± 110.0 475.0a±105.0 580.5b ± 9 7 . 1 430.0b±114.9

Ascorbic acid (mg) 39.1a± 15.4 42.4a ± 14.2 37.2b ± 9 . 8 40.6b ± 13.4

Thiamine (mg) 1.2a ± 0 . 7 1.1a ± 0 . 3 1.0b ± 0 . 5 0.9b ± 0 . 5

Riboflavin (mg) 1.2a ± 0 . 5 l.la±0.6 1.2b ± 0 . 3 1.1b ± 0 . 4

Niacin (mg) 14a ± 5.6 12 a± 5.5 12b ± 9 . 4 l l b ± 10.2

* No RDA. The suesested intake is Fat >30e and Carbohydrate!3 >150g
Any two means in columns carrying different superscripts a, b, c .
differ significantly (p<0.05)

209
 Table 72. Effect of GEF on the anthropometric measurements
and indices of Group I patients

Men Women
Measurement/index
Initial Final Initial Final
Experimental
Height 168.2 168.2 156.4 156.4
Weight 61.2 62.0 57.1 57.9
Body Mass Index 17.8 18.0 18.0 18.2
MUAC 26.8 27.3 25.8 26.1
Skin fold thickness 17.0 19.0 18.0 19.0
MUAMC 20.2 20.4 21.3 21.5
Control
Height 168.2 168.2 156.2 156.2
Weight 62.3 63.6 56.4 56.8
Body Mass Index 17.6 17.8 18.1 18.2
MUAC 27.6 27.8 25.3 25.4
Skin fold thickness 18.0 19.0 17.0 18.0
MUAMC 21.4 21.5 21.1 21.3

210
Effect of GEF on the somatic status of Group I patients expressed as

percentiles is shown in Table 73. The data indicated that significant

number of patients moved towards normal energy and protein status

by the criteria of BMI, MUAC, MUAMC and SFT as compared to

patients in the control group. Effect of GEF on the selected

biochemical parameters of Group 1 patients is presented in Table 74.

There was a significant change in the haemoglobin levels with more

patients moving towards normal levels in experimental group than

control group. At the end of 21 days, the percent of patients having

very low levels of haemoglobin decreased from 57% to 36% in the

experimental group whereas, in the control group, the decrease was

observed to be small i.e. from initial 56% to 45% in the final. Thus,

GEF improved the haemoglobin levels of experimental group patients

significantly.

The mean change in the somatic status of Group I patients

over a period of 21 days is shown in Figure 19. It could be seen that

the change was more positive in the experimental group than the

control group.

Serum total proteins and albumin levels of the Group I

patients are also shown in Table 74. While there was an

improvement in total serum protein levels, which was higher in the

experimental group, the increase in the serum albumin level was not

significant comparatively. However, it was observed that there was a

211
Table 7 3 . Effect of GEF on the somatic status of Group I patients
Classification Experimental Control
Initial Final Initial Final
BMI
<18.5 56 50 55 51
18.5-24.9 31 40 23 28
25-29.9 8 7 9 9
30-34.9 4 3 9 8
35-39.9 1 0 4 4
MUAC
<60 50 38 47 40
61-70 28 33 25 27
71-80 10 14 17 21
81-90 10 13 10 11
>90 2 2 1 1
SFT
<60 41 32 40 36
61-70 26 32 34 26
71-80 17 16 12 21
81-90 11 14 11 13
>90 5 6 3 4
MUAMC
<60 51 36 45 38
61-70 26 32 24 24
71-80 9 13 18 21
81-90 11 13 10 12
>90 3 6 3 5

212
 Weight Body Mass Index MUAC Skin fold MUAMC
thickness

Figure 19. Effect of GEF on the somatic status of Group I

patients over a period of 21 days

213
 Table 74. Effect of GBF on the biochemical parameters of Group
I patients

Classification Experimental Control

Initial Final Initial Final
S. Total protein
<6.8 57.0 38.0 56.0 44.0
6.8-8.0 37.0 58.0 37.0 50.0
>8.0 6.0 4.0 7.0 6.0
S. Albumin
<3.8 58.0 40.0 55.0 42.0
3.8-5.4 36.0 54.0 38.0 53.0
>5.4 6.0 6.0 7.0 5.0
Haemoglobin
7-9.9 57.0 36.0 56.0 45.0
10-11.9 31.0 44.0 33.0 39.0
>12 12.0 20.0 11.0 16.0

214
decrease in the serum albumin levels in a few of the patients under

the control group. It is reported that levels of serum albumin remain

almost constant or even decrease under hypercatabolic state. It is

possible that longer duration may be needed for significant increase

in albumin levels. Changes in the selected biochemical parameters of

the Group I patients due to GEF are shown in Figure 20. The data

indicates that more number of patients showed near-normal values

in the experimental group than the control group.

Discussion

It is evident from the results of the study that the enteral food

formulated to meet the nutritional needs of the patients under

general category was beneficial. It is a fact that adequate nutritional

support does improve the fat and protein stores which in turn would

reduce the extent of malnutrition. It was observed that the subjects

under the general category were primarily surgical patients. Patients

who are malnourished to start with have an increased incidence of

post-operative complications such as sepsis, wound dehiscence and

ileus (102). In addition, their immune status and pulmonary

functions are impaired, which predisposes them to an increased rate

of complications.

Hence, timely and adequate nutritional support to a patient

plays an important role in improving the clinical outcome and

215
 14
I Experimental • Control
12

10

0 E3 _
c c 1-
o o »>
1 "5 o
o OT
CD
^
I s
</) Q-
O
3
<
(0 (0
OT

Figure 2 0 . Effect of GEF on the biochemical parameters of Group

I patients over a period of 21 days

216
decreasing morbidity and mortality rates. It was observed that more

number of patients moved towards better nutritional status with the

food formulated specifically to meet the nutritional needs of this

category of patients.

C. EFFECT OF FEEDING THE FORMULATED ENTERAL FOOD -

CSEF TO CANCER PATIENTS.

Since it was a purposeful sampling, subjects in this group

were primarily head and neck cancer patients, it was observed that

most of the patients were scheduled to undergo surgery for the

cancer. Initially on hospitalisation, if the patient was able to take

food orally, they were put on oral feeding and subsequently they were

started on enteral feeding when required or a day preoperatively.

Type and volume of the oral/enteral feeding given to the patients

under this category is shown in Table 75. The total volume as well

as the volume per feed given to the patients was lower in the

experimental group than the control group. Hence, the number of

feeds required for a day's feeding was also less (5-8) in the

experimental group compared to the control grop (6-9). Feeding

regimen of the selected patients under CSEF category is given in

Table 76. In case of control group, the feeding regimen included

foods such as soups, dal, soya milk, eggs, fruit juices, coconut water

etc. In addition, Resource'^'^ was also being given for one feed. Honey

and butter had to be added to the regimen to increase the energy

217
 Table 75. Details of nutritional support of Group II CSEF
patients

No. of patients
Experimental Control
(n=10) (n=10)
Oral feeding (Initial) 10 10
Enteral feeding
Pre-operative 8 9
Peri-operative 9 7
Post-operative 10 10
Mean
No. of feeds 5-8 6-9
Volume per feed 240 ± 30 ml 270 ± 35 ml
200 - 325 235 - 350
Total volume of feeds 1965 ± 40 ml 2350 ± 50 ml
1125-2155 1370-2715

218
Table 76. Feeding regimen (Isocaloric) of Group II CSBF patients
Control Experimental
Time Foods Quantity Time Foods Quantity

6:30AM Milk + Egg + 250 8:00AM 280

CSEF
Butter
Soya milk/
8:30AM Resource''''^ + 250 11:00AM CSEF 220
honey
Sweet
10:30AM lime/fresh fruit 250 1:00PM CSEF 320
juice
12:30PM Dal + Soup + 325 4:00PM CSEF 220
Rice broth
3:30PM Coconut water 250 6:00PM CSEF 220
5:00PM Milk + butter 250 8:00PM CSEF 320
7:00PM Groundnut milk 250 10:00PM CSEF 220
+ honey
9:00PM Dal + Soya + 325
rice/ragi broth
11:00PM Milk + butter 250
Total amount/day 2400 1800

219
content to match the energy content of the formulated GEF being

given to the experimental group of patients. Mean energy and

nutrient intake of Group I patients is presented in Table 77. Being

isocaloric, the energy content of the diets was almost similar for the

experimental and control groups. Although, the nutrient intake of

the patients on the experimental and control groups were

comparable, the nutrient intake of the experimental group especially

with respect to micronutrients was significantly higher than that of

the control group.

Effect of CSEF on the anthropometric measurements and

indices of Group II patients is shown in Table 78. It was seen that

there was an increase in the measurements and indices in

experimental as well as control groups. However, the increases were

higher in the experimental group compared to the control group.

Effect of CSEF on the somatic status of Group II patients expressed

as percentiles is shown in Table 79. The data indicated that by the

criteria of BMI, MUAC, MUAMC and SFT, a significant number of

patients moved towards normal energy and protein status as

compared to patients in the control group. Effect of CSEF on the

selected biochemical parameters of Group II patients is presented in

Table 80. Haemoglobin levels showed a significant change with more

patients moving towards normal levels in experimental group than

control group. At the end of 21 days, the percent of patients

220
 Table 77. Mean energy and nutrient intake of
Group II CSEF patients

Nutrient Men Women

Experimental Control Experimental Control

E n e r g y (Kcal) 1990a ± 4 5 . 6 1985a ± 55.0 1805b ± 125.9 1815b ±

135.5

P r o t e i n (g) 60.2a ± 14.7 57.4a ± 12.6 42.9b ± 10.8 40.3b ± 13.8

F a t (g) 33.4a ± 14.4 32.4a ± 12.5 28.8b ± 11.4 28.6b ± 12.5

C a r b o h y d r a t e (g) 340.5a ± 40.7 335.0a ±32.2 305.5b ± 4 0 . 2 295.5b ± 36.8

C a l c i u m (mg) 380.0a ± 90.2 325.0a ±93.5 225.5b ± 90.4 220.0b ± 8 5 . 5

I r o n (mg) 28.3a ± 10.1 24.0a ± 11.3 21.4b ± 13.5 21.0b ± 9 . 9

R e t i n o l (jug) 560.0a ± 9 5 . 3 435.5a± 100.5 340.5b±110.3 345.5b±l 15.7

A s c o r b i c a c i d (mg) 38.7a± 13.3 32.1a ± 15.4 39.0b ± 11.2 32.1b ± 12.3

T h i a m i n e (mg) 1.2a ± 0 . 6 1.2a ± 0 . 5 1.2b ± 0 . 4 1.0b ± 0 . 4

Riboflavin (mg) 1.3a ± 0 . 6 1.3a ± 0 . 5 1.2b ± 0 . 3 1.1b ± 0 . 4

N i a c i n (mg) 16a ± 7 . 8 14a ± 6 . 8 12b± 11.1 lib ±9.6

* No RDA. The suggested intake is Fat >30g and Carbohydrates >150g
Any two means in columns carrying different superscripts a, b, c .
differ significantly (p<0.05)

221
Table 78. Effect of CSEF on the anthropometric measurements
and indices of Group II patients

Men Women
Measurement/ index
Initial Final Initial Final
Experimental
Height 167.0 167.0 155.4 155.4
Weight 60.6 62.1 56.1 56.9
Body Mass Index 17.1 17.3 18.2 18.3
MUAC 26.5 27.0 25.6 26.1
Skin fold thickness 17.0 21.0 18.0 20.0
MUAMC 20.2 20.4 21.3 21.6
Control
Height 164.8 164.8 156.5 156.5
Weight 61.1 62.7 57.5 57.9
Body Mass Index 17.3 17.4 18.0 18.2
MUAC 28.2 28.4 27.3 27.5
Skin fold thickness 17.0 19.0 17.0 18.0
MUAMC 20.1 20.2 21.3 21.5

222
Table 79. Effect of CSEF on the somatic status of Group II
patients
Classification Experimental Control
Initial Final Initial Final
BMI
<18.5 52 42 59 52
18.5-24.9 30 46 21 33
25-29.9 10 8 8 7
30-34.9 5 3 8 6
35-39.9 3 1 4 2
>40 0 0 0 0
MUAC
<60 51 32 45 36
61-70 28 22 30 28
71-80 11 26 12 22
81-90 6 12 9 10
>90 3 8 4 4
SFT
<60 40 31 42 31
61-70 24 22 28 25
71-80 19 20 9 23
81-90 11 18 13 13
>90 6 9 8 9
MUAMC
<60 47 32 44 36
61-70 29 30 28 31
71-80 9 15 11 13
81-90 11 15 11 13
>90 4 8 6 7

223
 Table 80. Effect of CSEF on the biochemical parameters of
Group II patients

Classification Experimental Control

Initial Final Initial Final
S. Total protein
<6.8 58.0 44.0 57.0 48.0
6.8-8.0 36.0 53.0 38.0 47.0
>8.0 6.0 3.0 5.0 5.0
S. Albumin
<3.8 55.0 41.0 58.0 45.0
3.8-5.4 39.0 55.0 37.0 49.0
>5.4 6.0 4.0 5.0 6.0
Haemoglobin
7-9.9 55.0 38.0 55.0 49.0
10-11.9 35.0 41.0 36.0 39.0
>12 10.0 21.0 9.0 12.0

224
categorised as having moderate anaemia decreased from 55% to 38%

in the experimental group whereas, in the control group, the

decrease was observed to be smaller i.e. from initial 55% to 49% in

the final. A significantly higher number of patients moved to the

normal level in experimental group at the end of the study period

(21%) compared to the control patients (12%). Thus, it can be said

that CSEF improved the haemoglobin levels of the experimental

group patients significantly.

The mean change in the somatic status of Group II patients

over a period of 21 days is shown in Figure 2 1 . It was noticed that

the changes were more positive in the experimental group than the

control group.

Serum total proteins and albumin levels of the Group II

patients are also shown in Table 80. While there was an

improvement in total serum protein levels, which was higher in the

experimental group, the increase in the serum albumin level was not

significant comparatively. Since it is reported that levels of serum

albumin may decrease under hypercatabolic state, it is possible that

a longer duration may be needed for further increases in albumin

levels.

Changes in the selected biochemical parameters of the Group

II patients due to CSEF are shown in Figure 22. The data indicates

225
 Weight Body Mass Index MUAC Skin fold MUAMC
thickness

Figure 2 1 . Effect of CSEF on the somatic status of Group II

patients over a period of 21 days

226
10
I Experimental B Control |

i
V L i c* Q_ -•
1
1 u
3
en
E
11 3
"XT"
CO «

to

Figure 2 2 . Effect of CSEF on the biochemical parameters of

Group II patients over a period of 21 days

227
that more number of patients moved towards normal values in the

experimental group than the control group.

Discussion

Cancer, which affects people at all ages is one of the principal

causes of death. Head and neck cancer though constitutes about 5%

of all cancers, is reported to have a greater negative impact in the

patient's food intake and thus the nutritional status besides having a

psychological effect. In a majority of cancer cases, cachexia has been

found at some point or their illness. Cachexia may result in weight

loss, anorexia, anaemia and abnormalities in intermediary

metabolism (153). Thus, head and neck cancer may result in further

increase in the severity of malnutrition. In addition. Malabsorption

and increased nutrient losses also contribute to the increase in

malnutrition. Thus, nutritional status support plays an important

role in head and neck cancers and these patients often require

specialised support through the enteral route.

The results of the present study indicated that the cancer-

specific formulation was able to provide adequate nutritional support

to these patients as indicated by the improvements seen in their

somatic and biochemical indicators. The results are indicative of the

fact that it is possible to provide nutritional support by the addition

228
of specific foods/nutraceuticals viz., soya, coconut oil, argenine,

glutamine etc to the enteral formulations.

D. EFFECT OF FEEDING THE FORMULATED ENTERAL FOOD -

DSEF TO DIABETIC PATIENTS.
Subjects in this group were primarily surgical patients with

Type 2 diabetes. Type 1 diabetic subjects were excluded from the

study since the various types of insulin prescribed as well as its

dosage may cause significant changes in metabolism and act as a

confounding variable. Initially on hospitalisation, the patient was put

on oral feeding and subsequently started on enteral feeding when

required or j u s t before surgery. Type and volume of the oral/enteral

feeding given to the patients under this category is shown in Table

81. It was noted that the total volume as well as the volume per feed

given to the patients was lower in the experimental group than the

control group. Hence, the number of feeds required for a day's

feeding was also less (5-9) in the experimental group with some

patients the control group requiring up to 10 feeds in a day. Feeding

regimen of the selected patients under CSEF category is given in

Table 82. Feeding regimen of the control group included foods such

as soup, dal, rice broth, soya, eggs, fruit juices, coconut water etc. If

required in addition, Resource Diabetic''''^ was being given for only

one feed. Unlike other groups, honey could not be added to the

regimen to increase the energy content. Mean energy and nutrient

intake of Group III patients is presented in Table 83. Since the diets
229
 Table 8 1 . Details of nutritional support of Group III DSEF
patients

No. of patients
Experimental Control
(n=9) (n=ll)
Oral feeding (Initial) 9 10
Enteral feeding
Pre-operative 8 9
Peri-operative 8 11
Post-operative 9 11
Mean
No. of feeds 5-9 6-10
Volume per feed 250 ± 30 ml 280 ± 40 ml
220 - 325 250 - 360
Total volume of feeds 1975 ± 50 ml 2460 ± 55 ml
1245 - 2265 1470 - 2800

230
 Table 8 2 . Feeding regimen (Isocaloric) of Group III DSEF
patients
Control Experimental
Time Foods Quantity Time Foods Quantity
6:30AM Milk + Egg 220 8:00AM DSEF 240
8:30AM Soya milk 240 11:00AM DSEF 220
Sweet
10:30AM lime/fresh fruit 240 1:00PM DSEF 320
juice
12:30PM Dal + Veg soup 350 4:00PM DSEF 220
+ Rice broth
3:30PM Coconut water 240 6:00PM DSEF 220
5:00PM Resource 240 8:00PM 320
DiabeticTM DSEF
7:00PM Groundnut milk 240 10:00PM DSEF 240
9:00PM Dal + Soya + 350
rice/ragi broth
11:00PM Milk + butter 220
Total amount/day 2340 1780

231
 Table 8 3 . Mean energy and nutrient intake of
Group III DSEF patients

Men Women
Nutrient
Experimental Control Experimental Control

Energy (Kcal) 2140a±55.8 2100a ±50.2 1885b ± 125.4 1895b ±115.1

Protein (g) 59.1«± 14.8 58.5a ± 13.6 50.2b ± 10.8 48.2b ± 13.8

Fat (g) 28.5^ ± 14.4 30.1a ± 12.5 27.9b ± 11.4 28.1b ± 12.5

Carbohydrate (g) 320.5« ± 40.7 325.0a ±32.2 300.0b ± 40.0 305.0b ± 3 6 . 5

Calcium (mg) 380.5a ± 90.2 350.0a ±93.5 375.5b ± 90.4 340.5b ± 8 5 . 5

Iron (mg) 27.6a ± 10.1 24.2a ± 11.3 27.2b ± 13.5 22.2b ± 9.9

Retinol (ng) 520.5a ± 9 9 . 1 505.0a± 105.4 540.5b± 100.2 500.0b±115.7

Ascorbic acid (mg) 38.7a ± 1 1 . 2 36.2a ± 12.8 37.9b ± 11.2 36.1b ± 12.3

Thiamine (mg) 1.2a ± 0 . 6 1.2a ± 0 . 5 1.1b ± 0 . 4 Lib ± 0 . 5

Riboflavin (mg) 1.3a ± 0 . 6 1.3a ± 0 . 5 1.2b ± 0 . 5 1.2b ± 0 . 4

Niacin (mg) 15a ± 7 . 8 14a ± 6.8 12b± 12.1 12 b± 9.4

* No RDA. The suggested intake is Fat >30g and Carbohydrates >150g
Any two means in columns carrying different superscripts a, b, c .
differ significantly (ps0.05)

232
were isocaloric, the energy content of the diets was similar for the

experimental and control groups. Although, the nutrient intake of

the patients on the experimental and control groups were

comparable, the carbohydrate and fat intake of the experimental

group was slightly lower than that of the control group.

Effect of DSEF on the anthropometric measurements and

indices of Group III patients is shown in Table 84. It was noted that

there was an increase in all the measurements except height in

experimental as well as control groups. However, the increases were

found to be higher in the experimental group when compared to the

control group. Effect of DSEF on the somatic status of Group III

patients expressed as percentiles is shown in Table 85. The data

indicated that a significant number of patients moved towards

normal energy and protein status by the criteria of BMI, MUAC,

MUAMC and SFT as compared to patients in the control group.

Effect of DSEF on the selected biochemical parameters of Group III

patients is presented in Table 86. Haemoglobin levels showed a

significant change with more patients moving towards normal levels

in experimental group than control group, especially from the

moderately anaemic group (7-9.9mg/dL). A significantly higher

number of patients moved to the normal level in experimental group

at the end of the study period (18%) compared to the control patients

233
Table 84. Effect of DSEF on the anthropometric measurements
and indices of Group III patients

Men Women
Measurement / index
Initial Final Initial Final
Experimental
Height 164.4 164.4 156.1 156.1
Weight 61.2 62.2 57.1 57.9
Body Mass Index 17.8 18.0 18.0 18.2
MUAC 25.5 26.1 25.8 26.3
Skin fold thickness 17.0 20.0 18.0 19.0
MUAMC 21.3 21.5 20.2 20.5
Control
Height 165.0 165.0 152.1 152.1
Weight 63.1 63.6 56.8 57.3
Body Mass Index 18.4 18.6 17.1 17.2
MUAC 26.7 26.8 25.3 25.5
Skin fold thickness 18.0 19.0 17.0 19.0
MUAMC 21.3 21.5 20.1 20.3

234
Table 85. Effect of DSEF on the somatic status of Group III
patients
Classification Experimental Control
Initial Final Initial Final
BMI
<18.5 51 41 48 40
18.5-24.9 35 47 35 45
25-29.9 6 7 7 7
30-34.9 6 4 8 7
35-39.9 2 1 2 1
>40 0 0 0 0
MUAC
<60 37 28 42 38
61-70 29 29 31 26
71-80 13 17 14 17
81-90 12 15 8 12
>90 9 11 5 7
SFT
<60 39 26 42 30
61-70 21 24 15 21
71-80 19 21 19 21
81-90 11 16 15 18
>90 10 13 9 10
MUAMC
<60 37 28 39 30
61-70 22 30 19 28
71-80 18 16 15 11
81-90 14 16 18 20
>90 9 10 9 11

235
 Table 86. Effect of DSEF on the biochemical p a r a m e t e r s of
Group III p a t i e n t s

Classification Experimental Control

Initial Final Initial Final
S. Total protein
<6.8 57.0 41.0 55.0 44.0
6.8-8.0 40.0 58.0 42.0 54.0
>8.0 3.0 1.0 3.0 2.0
S. Albumin
<3.8 57.0 39.0 59.0 43.0
3.8-5.4 39.0 59.0 38.0 54.0
>5.4 4.0 2.0 3.0 3.0
Haemoglobin
7-9.9 54.0 36.0 59.0 47.0
10-11.9 38.0 46.0 34.0 44.0
>12 8.0 18.0 7.0 9.0

236
(9%), Hence, it can be said that CSEF improved the haemoglobin

levels of the experimental group patients significantly.

The mean change in the somatic status of Group III patients

over a period of 21 days is shown in Figure 23. It was noticed that

the changes were more positive in the experimental group than the

control group.

Serum total proteins and albumin levels of the Group III

patients are also shown in Table 86. While there was an

improvement in total serum protein levels, it was higher in the

experimental group. Improvement in the albumin levels was also

noticed in the experimental as well as control group, though the

improvement was higher in the experimental group.

Changes in the selected biochemical parameters of the Group

III patients due to DSEF are shown in Figure 24. The data showed

that more number of patients in the experimental group than the

control group moved towards normal values.

Discussion

It is well known that diabetes is the single most important

metabolic disease and can affect nearly ever organ system in the

body. As per the reports, the prevalence of diabetes in hospitalised

237
 Weight Body Mass Index MUAC Skin fold MUAMC
thickness

Figure 2 3 . Effect of DSEF on the somatic status of Group III

patients over a period of 21 days

238
Figure 2 4 . Effect of DSEF on the biochemical parameters of
Group III patients over a period of 21 days

239
adults is estimated to be about 25% (144.). It is generally

acknowledged that hospitalisation costs increase with diabetes and

studies have associated diabetes with adverse hospital outcomes. It

has been shown that improved glycaemic control may have a positive

effect on the immune function and heart function besides lowering

inflammatory mediators (147). It has been established that

nutritional therapy can play an important role in the medical

management for all patients with diabetes.

In the present study, the assessment of nutritional status of

these patients with Type 2 diabetes indicated the presence of

considerable protein, energy malnutrition by their somatic status

and serum levels of haemoglobin and serum protein/albumin.

Hence, the primary goal of nutritional support should be to provide

appropriate protein, energy and other nutrients that promote

glycaemic control and reduce the risk of short- and long-term

complications of diabetes. The formulated disease-specific enteral

food having higher amounts of dietary fibre particularly soluble

dietary fibre and lower starch digestibility index was found to be

beneficial to these patients as indicated by their blood glucose levels.

In addition, it had also improved the nutritional status as evident by

the positive changes in somatic status and biochemical parameters

viz., haemoglobin, serum protein and albumin.

240
 Hence, the data confirms that is possible to provide nutritional

support for diabetic patients through specially designed foods

specific to control diabetes without affecting the treatment of other

co-morbidities in critically ill patients.

E. EFFECT OF FEEDING THE FORMULATED ENTERAL FOOD -

HSEF TO HIV/AIDS PATIENTS.

Due to restrictive protocols followed in a number of hospitals

with respect to the treatment of HIV positive or AIDS patients, it was

possible to enrol only 6 surgical HIV/AIDS patients for the study. Of

these 6 patients 2 had developed AIDS while the others were HIV

positive, but stayed asymptomatic. On hospitalisation, initially the

patient was put on oral feeding if tolerated and subsequently started

on enteral feeding when required or just before surgery. Type and

volume of the oral/enteral feeding given to the patients under this

category is shown in Table 87. It was observed that the total volume

as well as the volume per feed given to the patients was lower in the

experimental group than the control group. It was also noted that of

all the groups, every patient in this group was fed pre-peri- and post-

operatively using enteral feeding. This was done because HIV/AIDS

patients are generally malnourished due to physiological as well as

psychosocial aspects of this disease and require immediate

nutritional repletion to withstand treatment. Feeding regimen of the

selected patients under HSEF category is given in Table 88. Feeding

regimen of the control group included foods such as soup, dal,

241
 Table 87. Details of nutritional support of Group IV HSEF
patients

No. of patients
Experimental Control
(n=3) (n=3)
Oral feeding (Initial) 3 3
Enteral feeding
Pre-operative 3 3
Peri-operative 3 3
Post-operative 3 3
Mean
No. of feeds 5-8 6-9
Volume per feed 250 ± 40 ml 280 ± 50 ml
215-320 245 - 350
Total volume of feeds 2015 ± 3 5 ml 2445 ± 45 ml
1215-2205 1575 - 2720

242
Table 88. Feeding regimen (Isocaloric) of Group IV HSBF patients
Control Experimental
Time Foods Quantity Time Foods Quantity

6:30AM Milk + Egg + 250 8:00AM 250

HSEF
Butter
8:30AM Soya milk + 250 11:00AM 225
HSEF
honey
Sweet
10:30AM lime/fresh fruit 250 1:00PM HSEF 350
juice
12:30PM Dal + Soup + 350 3:00PM 225
HSEF
Rice broth
3:30PM Coconut water 250 5:00PM HSEF 225
5:00PM Milk/ 250 7:00PM 225
HSEF
Resource^"^
7:00PM Groundnut milk 250 9:00PM 350
HSEF
+ honey
9:00PM Dal + Soya + 350 11:00PM 250
HSEF
rice/ragi broth
11:00PM Milk + butter 250
Total amount/day 2450 1850

243
rice/ragi broth, soya, eggs, fruit juices, coconut water etc. In

addition, Resource "^"^ was being given daily for one feed. Honey as

well as butter was added to the regimen to increase the energy

content without increasing the bulk of the diet. Mean energy and

nutrient intake of Group IV patients is presented in Table 89. As the

diets were isocaloric, the energy content of the diets was similar for

the experimental and control groups. The nutrient intake of the

patients on the experimental and control groups was also found to be

comparable.

Effect of HSEF on the anthropometric measurements and

indices of Group IV patients is shown in Table 90. It was noted that

there was a slight increase in the measurements and indices in

experimental as well as control groups. However, the increase was

found to be higher in the experimental group compared to the control

group. Effect of HSEF on the somatic status of Group IV patients

expressed as percentiles is shown in Table 9 1 . The data showed that

a significant number of patients moved towards normal energy and

protein status by the criteria of BMl, MUAC, MUAMC and SFT

compared to patients in the control group. Effect of HSEF on the

selected biochemical parameters of Group IV patients is presented in

Table 92. Haemoglobin levels showed a significant change with more

patients moving towards normal levels in experimental group than

control group, from the moderately anaemic group (7-9.9mg/dL) as

244
 Table 8 9 . Mean energy and n u t r i e n t i n t a k e o f
Group IV HSEF p a t i e n t s

Men Women
Nutrient
Experimental Control Experimental Control

Energy (Kcal) 2060a ± 55.8 1990a ± 50.0 1935b ± 125.9 1915b ±135.5

Protein (g) 60.2«± 15.2 58.1a± 16.2 50.1b± 10.8 46.4b ± 13.8

Fat (g) 33.2a ± 13.5 33.4a ± 14.7 28.5b ± 11.4 29.6b ± 12.2

Carbohydrate (g) 350.0a ±40.1 340.5a ±32.5 340.0b ± 36.9 315.0b ±32.5

Calcium (mg) 385.5a ± 80.5 355.0a ±90.5 365.5b ± 90.4 320.0b ± 85.5

Iron (mg) 28.3a ± 10.4 26.5a ±11.13 27.6b ± 11.4 27.4b ± 12.3

Retinol (|ig) 560.0a ± 95.0 505.0a ±95.6 540.5b ±110.3 395.0b±115.7

Ascorbic acid (mg) 37.4a ± 13.6 38.9a ± 15.4 38.7b ± 13.2 33.8b ± 11.3

Thiamine (mg) 1.1a ± 0 . 3 1.1a ± 0 . 7 1.2b ± 0 . 8 1.0b ±0.6

Riboflavin (mg) 1.2a ±0.4 1.2a ± 0 . 8 1.2b ± 0 . 2 1.1b ±0.6

Niacin (mg) 13a ± 6 . 8 12a ± 6 . 8 12b± 10.1 l i b ±6.9

* No RDA. The suggested intake is Fat >30g and Carbohydrates >150g
Any two means in columns carrying different superscripts a, b, c . differ
significantly (p^0.05)

245
Table 9 0 . BfTect of HSEF on the anthropometric measurements
and indices of Group IV patients

Men Women
Measurement/index
Initial Final Initial Final
Experimental
Height 161.4 161.4 151.6 151.6
Weight 61.2 62.1 57.1 58.1
Body Mass Index 17.8 18.1 18.0 18.2
MUAC 27.5 28.2 25.6 26.1
Skin fold thickness 17.0 21.0 18.0 21.0
MUAMC 20.8 21.2 20.3 20.8
Control
Height 162.8 162.8 152.7 152.7
Weight 62.3 63.0 55.4 56.1
Body Mass Index 17.6 17.8 18.1 18.2
MUAC 26.6 26.9 25.3 25.6
Skin fold thickness 18.0 21.0 17.0 20.0
MUAMC 21.4 21.5 21.1 21.3

246
Table 9 1 . Effect of HSEF on the somatic status of Group IV
patients
Classification Experimental Control
Initial Final Initial Final
BMI
<18.5 58 41 57 42
18.5-24.9 38 55 40 55
25-29.9 2 2 1 2
30-34.9 2 2 2 1
35-39.9 0 0 0 0
>40 0 0 0 0
MUAC
<60 58 27 56 42
61-70 25 40 26 30
71-80 12 22 10 15
81-90 5 11 8 13
>90 0 0 0 0
SFT
<60 55 28 50 38
61-70 26 23 22 24
71-80 10 34 14 20
81-90 7 12 12 15
>90 2 3 2 3
MUAMC
<60 56 28 53 38
61-70 21 36 27 34
71-80 13 24 10 15
81-90 9 11 10 12
>90 1 1 0 1

247
 Table 92. Effect of HSEF on the biochemical parameters of
Group IV patients

Classification Experimental Control

Initial Final Initial Final
S. Total protein
<6.8 66.7 16.6 66.7 50.0
6.8-8.0 33.3 83.4 33.3 50.0
>8.0 0.0 0.0 0.0 0.0
S. Albumin
<3.8 50.0 33.3 66.7 50.0
3.8-5.4 50.0 66.7 33.3 50.0
>5.4 0.0 0.0 0.0 0.0
Haemoglobin
7-9.9 50.0 16.6 50.0 50.0
10-11.9 33.4 33.4 50.0 50.0
>12 16.6 50.0 0.0 0.0

248
well as to the normal range (>12.0mg/dL). A significant number of

patients moved to the normal level in experimental group at the end

of the study period (50%) while no control patient improved their

haemoglobin status. Hence, it can be said that HSEF significantly

improved the haemoglobin levels of the experimental group patients.

The mean change in the somatic status of Group IV patients

over a period of 21 days is shown in Figure 25. It was noticed that

the changes were more positive in the experimental group than the

control group.

Serum total proteins and albumin levels of the Group IV

patients are also shown in Table 92. With respect to improvement in

total serum protein levels, it was significantly higher in the

experimental group than the control group where no much

improvement was seen. Improvement in the albumin levels was also

noticed in the experimental as well as control group, though the

improvement was much higher in the experimental group.

Changes in the selected biochemical parameters of the Group

IV patients due to HSEF are shown in Figure 26. The data shows

that more number of patients in the experimental group than the

control group moved towards normal values.

249
 Weight Body Mass Index MUAC Skin fold MUAMC
thickness

Figure 2 5 . Effect of HSEF on the somatic status of Group IV

patients over a period of 21 days

250
Figure 26. Effect of HSEF on the biochemical parameters of
Group rv patients over a period of 21 days

251
Discussion

Human immunodeficiency virus infection is found to be the

root cause of AIDS, which is considered to be the final stage of the

disease process which manifests in infections including tuberculosis.

Because of the related infections and other symptoms, it is likely to

affect the food intake resulting in malnutrition. In the state of

infection and malnutrition, which can severely affect the immune

system, the infected person may have a reduced tolerance to

medication and therapy. Hence, nutrition plays an important role in

the management of HIV/AIDS. Besides, malnutrition in HIV/AIDS

patient appears to be multi-factorial in nature and can increase

morbidity and mortality (23). Since drugs and treatment can interfere

with appetite and food behaviours, often oral intake may be limited

(52). Hence, enteral nutrition is the preferred route for nutritional

support in such patients (66).

Studies have also shown that enteral feeding is beneficial even

in the presence of a systemic infection for successful nutritional

repletion (36). In the present study, this group of patients also

showed an improvement in their severity of malnutrition an din the

visceral protein status. The formulated enteral food having been

made specific for HIV/AIDS patients by the addition of soya and milk

powder, which increased the protein content was found to contribute

to an appreciable improvement in the protein status. Hence, the data

252
confirms that nutritional support with specifically designed enteral

foods should be an essential part of any HIV/AIDS care package (67).

F. EFFECT OF FEEDING FORMULATED ENTERAL FOOD ON THE

CLINICAL OUTCOME OF THE SELECTED PATIENTS - ALL
GROUPS COMBINED
Effect of feeding formulated enteral feeds on the outcome

measures in the selected subjects - all groups combined is shown

using somatic status and biochemical parameters as indicators. The

data on the anthropometric measurements and indices is presented

in Table 93. Comparatively, more number of patients moved towards

the normal in the experimental group than in the control in all the

indices - BMI, MUAC, MUAMC and SFT. hence, at the end of 21

days, all patients under the experimental group showed improved

protein-energy status indicating successful nutritional repletion.

Though improvements were also seen in the control group, the effect

was seen to a lesser extent. Effect of enteral foods in the biochemical

parameters of the selected patients is presented in Table 94. The

magnitude of change in terms of serum total protein, serum albumin

and haemoglobin was much higher in the experimental group.

Thus, all the four formulated enteral foods conferred beneficial

effects on the nutritional status of the patients showing a positive

outcome of the nutritional support provided. It is expected that this

253
 AND ARCHIVAL SECTION
Table 93. Effect of enteral food on the anthropometric
measurements & indices of selected patients
-all groups combined*
[No. (%)]
Classification Experimental Control
Initial Final Initial Final
BMI
<18.5 54 44 55 46
18.5-24.9 34 47 30 40
25-29.9 7 6 6 6
30-34.9 4 3 7 6
35-39.9 2 1 3 2
MUAC
<60 49 34 48 37
61-70 28 28 28 30
71-80 12 20 13 19
81-90 8 13 9 12
>90 4 5 3 3
SFT
<60 44 29 44 34
61-70 24 25 25 24
71-80 18 23 14 21
81-90 8 15 13 15
>90 6 8 6 7
MUAMC
<60 48 34 45 36
61-70 25 30 25 29
71-80 16 17 14 15
81-90 7 14 12 14
>90 4 6 5 6
n = 66

254
Table 94. BfTect of enteral food on the biochemical parameters
of the selected patients* - all groups combined
[No. (%)]
Experimental Control
Initial Final Initial Final
S. Albumin
<3.8 49.5 42.5 58.3 59.5
3.8-5.4 47.3 55.5 38.0 36.8
>5.4 3.3 2.0 3.8 3.8
S. Total protein
<6.8 47.5 41.5 60.0 58.5
6.8-8.0 49.0 55.5 36.3 37.5
>8.0 3.5 3.0 3.8 4.0
Haemoglobin
7-9.9 48.0 39.8 58.3 57.8
10-11.9 42.3 44.0 35.0 34.5
>12 9.8 16.3 6.8 7.8
* n
« =
= 66

255
positive outcome in meeting the nutritional needs of the patients will

have a favourable impact on the medical therapy being followed.

Discussion

The results presented here clearly show that provision of

specially designed nutritional support based on the need-assessment

can help nutritional replenishment and may favourably alter the

course of the disease and response to treatment. Since in India,

malnutrition still continues to be a problem, it has to be assumed

that most of the patients enter the hospital with malnourishment

along with the disease. It is evident from the results of the present

study that most of the patients regardless of disease category were

showing varying degrees of protein-energy malnutrition which could

be attributed to a deficient dietary pattern amounting to 'semi-

starvation' of both, energy and micronutrients. In patients who were

semi-starved, three major tissue sources become available to meet

the energy requirements; somatic protein (skeletal muscle), visceral

protein and fat. Hence, these compartments of body composition

may be compromised on prolonged intake of deficient diet.

In the present study, it is observed that more cases of severe

malnutrition are indicated by MUAC (49%) and MUAMC (47%) than

SFT (44%). This indicates low body protein and fat stores which may

be attributed to an inadequate diet.

256
 The data of the present study also suggests that these

measurements can successfully be used as yardsticks to measure

and control malnutrition. These tools become important as it is

observed that often, in hospitals only weight is recorded for patients

ignoring the other measurements. Even height or arm circumference

which can easily be measured are not recorded. In the present study

too, except for weight, all other somatic measurements had to be

collected specifically for the study as they were not measured

routinely in any of the hospitals. Therefore it is suggested that the

simple measures of BMI and arm circumference with or without

serum albumin levels can be used to assess and monitor the

nutritional status. Since nutritional support has to be provided

based on individual assessment, it is recommended that in the

hospitals, provisions for carrying out nutritional assessment need to

be enforced first.

Thus, the study emphasises the importance of need-

assessment and provision of appropriate nutritional support tailored

to suit the patient's condition.

Therefore, it is evident from the results of the study that it is

possible to design novel functional food formulations using

indigenous processing methods to provide optimum nutritional

support that is condition specific and also cost-effective to patients

under critical care.

257