Bioactive Carbohydrates and Dietary Fibre 1 (2013) 3–9

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Dietary fibre: A chemical category or a health ingredient?

Glyn O. Phillipsa,b,n
a
Glyn O. Phillips Hydrocolloids Research Centre, Glyndŵr University, Wrexham, LL11 2AW Wales, UK
b
Phillips Hydrocolloids Research Ltd., 45 Old Bond Street, London W1S 4AQ, UK

art i cle i nfo ab st rac t

Article history: Consideration is given to the extent to which the definition of a dietary fibre should relate to
Received 4 May 2012 its chemical nature or to its physiological action. Whereas a dietary fibre needs to fulfil the
Received in revised form necessary condition of forming short-chain fatty acid in the colon, any specific health claim
28 December 2012 must be independently verified. Clarification is also required when interchangeable or
overlapping terms are used such as dietary fibre, prebiotic, and probiotic. For biomaterials

Keywords: which show biological activity, the extent to which the whole material provides the

Dietary fibre bioactivity relative to contribution of specific components needs to be determined. Despite

Polysaccharide the acceptance of an international definition of dietary fibre by Codex, individual countries

Short-chain fatty acids and regions tend also to adopt additional requirements. A dilemma could also arise if a

Prebiotic decision based on national health research is used to by-pass the cumbersome international

Probiotic regulatory approval procedures.

Codex & 2013 Elsevier Ltd. All rights reserved.

EFSA
Health claim

Contents

1. Chemical designation or physiological function? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4

2. Response of individual countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4
3. Overlapping definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
4. Dietary fibre and prebiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
5. The position of probiotics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5
6. Bioactive polysaccharides. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
7. What are the regulatory proven health benefits of dietary fibre? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
8. Medical intervention or regulation? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
9. Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8
Annex 1a FAO recommended method how to evaluate and substantiate that a product is a prebiotic . . . . . . . . . . . . . . . . .8
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9

n
Correspondence address: Glyn O. Phillips Hydrocolloids Research Centre, Glyndŵr University, Wrexham, LL11 2AW Wales, UK.
Tel.: þ44 2920 843298; fax: þ44 2920 843145.
E-mail address: phillipsglyn@aol.com

2212-6198/$ - see front matter & 2013 Elsevier Ltd. All rights reserved.
http://dx.doi.org/10.1016/j.bcdf.2012.12.001
4 Bioactive Carbohydrates and Dietary Fibre 1 (2013) 3 –9
1. Chemical designation or physiological
function?
It took more than 50 years from the time Hipsley (1953) first used
the term dietary fibre for the non-digestible constituents of plant
cell walls, before an international definition was adopted by
Codex Committee on Nutrition and Foods for Special Dietary
Uses (2009). The contortions and arguments, leading to this
historic conclusion, which took more than 10 years at least, have
been already reviewed (Phillips & Cui, 2011).
The 2009 meeting of Codex eventually agreed upon the
following definition:
Dietary fibre means carbohydrate polymers with 10 or
more monomeric units which are not hydrolysed by the
endogenous enzymes in the small intestine of humans and
belong to the following categories:
 edible carbohydrate polymers naturally occurring in the
food as consumed;
 carbohydrate polymers, which have been obtained; from food
raw material by physiological, or chemical means and which
have been shown to have a physiological effect or benefit to
health as demonstrated by generally accepted scientific
evidence to competent authorities; and
 synthetic carbohydrate polymers which have been shown
to have a physiological effect of benefit to health as
demonstrated by generally accepted scientific evidence
to competent authorities.
 Footnote 1: on lignin etc—this is pending adoption of
Methods of Analysis and Sampling.
 Footnote 2: decision on whether to include carbohydrates
with monomeric units from 3 to 9 should be left to national
authorities.
The Codex draft definition at the pre-final stage contained
the following:
Dietary fibre generally has properties such as
 decrease intestinal transit time and increase stools bulk;
 fermentable by colonic microflora;
 reduce blood total and/or LDL cholesterol levels; and
 reduce post-prandial blood glucose and/or insulin levels.
Such specific physiological outcomes were eventually rejected
as a result of an intervention by J.H. Cummings to represent the
detailed discussions of a FAO/WHO Expert Group (2007) on
‘‘Scientific Update on Carbohydrates in Human Nutrition’’ which
considered that a food component should be defined in the first
instance by its chemistry, not its function. The expert group was
also unconvinced that the definition of fibre should include
‘‘properties’’ of fibre, such as effects on transit time, fermentation
and lipid metabolism. These are not consistent effects of fibre
and in specifying them the Expert Group felt the definition was
moving to the province of health claims. Many factors could
contribute to their action in the human body other than their
fibre characteristics.
Essentially the viewpoint expressed is that different car-
bohydrates have quite different nutritional outcomes, which
can even be different for different people and populations.
Cummings and Stephen (2007) set out a comprehensive
characterisation of nutritional carbohydrates noting also
their principal physiological functions. When considering
dietary fibre, they return to the original definition by
Trowell (1972), as the ‘the proportion of food which is derived
from the cellular walls of plants which is digested very poorly
in human beings’. Indeed, the Expert Group, with Cummings
a leading member, had supported the view that dietary fibre
should be defined as ‘‘intrinsic plant cell wall polysaccharides’’.
2. Response of individual countries
In view of the general international acceptance of the basis of
the definition of dietary fibre by Codex, FAO/WHO and the EC,
individual countries are re-re-visiting their own published
positions. Here is an example of such a review by Health
Canada (2012). Their previous definition was
‘‘Dietary fibre consists of the endogenous components of
plant material in the diet which are resistant to digestion
by enzymes produced by humans. They are predomi-
nantly non-starch polysaccharides and lignin and may
include, in addition, associated substance’’ (Health and
Welfare Canada, 1985).
This was expanded in 1988 to add:
Novel Fibre or Novel Fibre Source means a food that is
manufactured to dietary fibre, and
 that has not traditionally been used for human consump-
tion to any significant extent, or
 that has been chemically processed, e.g. oxidised, or
physically processed, finely ground, so as to modify the
properties of the fibre contained therein; and
 that has been highly concentrated from its plant source
(Health Canada, 1988).
The new international position is now reflected in the follow-
ing new Definition of Dietary Fibre in Health Canada (2012):
‘‘Dietary fibre consists of: 1) carbohydrates with a DP1 of 3
or more that naturally occur in foods of plant origin and
that are not digested and absorbed by the small intestine;
and 2) accepted novel fibres.
Novel fibres are ingredients manufactured to be sources of
dietary fibre and consist of carbohydrates with a DP of 3 or
more that are not digested and absorbed by the small
intestine. They are synthetically produced or are obtained
from natural sources which have no history of safe use as
dietary fibre or which have been processed so as to modify
the properties of the fibre contained therein. Accepted
novel fibres have at least one physiological effect demon-
strated by generally accepted scientific evidence’’
Many stakeholders asked for more explicit explanation of
‘‘physiological effects’’ which were recognised by Health
Canada. As a result a fourth effect was added to the three
other effects previously accepted in 1997 about the energy
provided by metabolites:
1
DP ¼degree of polymerisation or number of saccharide units.
 Bioactive Carbohydrates and Dietary Fibre 1 (2013) 3 –9
Dietary fibre:
 improves laxation or regularity by increasing stool bulk;
 reduces blood total and/or LDL cholesterol levels;
 reduces post-prandial blood glucose and/or insulin levels; and
 provides energy-yielding metabolites through colonic
fermentation.
Before use in Canada a novel dietary fibre without a history
of food use must prove its safely and a demonstrable physio-
logical effect must be established. Thus, there is a need to
conform to individual country’s regulations, which could be
somewhat different to the basic requirements of Codex.
3. Overlapping definitions
What then is the term ‘‘dietary fibre’’ intended to do? Is it
designed to identify a specific category of carbohydrate which
immediately conveys the impression that it will impart a health
benefit by acting physiologically in a particular manner? If it can
be shown that it is not metabolised in the stomach but passes
into the colon where it is bacterially fermented to give short-
chain fatty acids, is this sufficient to promote it as a healthy food?
It is important to recognise that nutritional functions can
overlap for carbohydrates which have, for good practical reasons,
been given a label which points to some physical, chemical or
metabolic characteristic. For example the terms ‘‘dietary fibres’’,
‘‘non-starch polysaccharides’’ and ‘‘prebiotics’’ can be applied to
the same polysaccharide. The subject has suffered from being
fragmented with chemical and biological observations often
being presented in unrelated contexts. Usually the physiology
aspects have taken preference over the functional material
component’s specific characteristics. For example the definition:
‘A prebiotic is a non-digestible food ingredient that beneficially affects
the host by selectively stimulating the growth and/or activity of one of a
limited number of bacteria in the colon, and thus improves host health’
(Gibson, Probert, Van Loo, Rastall, & Roberfroid, 2004). However,
‘‘dietary fibre’’ and ‘‘non-starch polysaccharides can act in the
same way. The terms do not represent a single chemical
category, but each might well represent a health benefit. Their
independent use could have a useful function. Short chain
polysaccharide production in the human colon influences the
fuel energy availability from the substrate, could control move-
ment of water out of the colon lumen, play an important role in
maintaining mucosal integrity and possibly influence the inci-
dence of small bowel cancer and lower serum cholesterol etc.
(Cummings & Macfarlane, 1991).
4. Dietary fibre and prebiotics
An FAO Report (2007) stated that the market for prebiotics in
food is growing rapidly and at that time there are over 400
prebiotic food products and more than 20 companies produ-
cing oligosaccharides and fibres used as ‘‘prebiotics’’. A Frost
& Sullivan review on The World Prebiotic Ingredient Market
(http://www.ubic-consulting.com/template/fs/The-World-Pre
biotic-Ingredient-Market.pdf) reported that the European pre
biotics market in 2007 was worth 87 million euro, and
predicted that it would reach 179.7 million euro by 2010.
5
They report that prebiotics were being examined for anti
pathogenic effects (such as inhibiting adhesion of pathogenic
organisms to the gut mucosa), and also being developed to
decrease faecal transit time, lower cholesterol and the glycae
mic response, improve bone health, lower daily energy (fat)
intake, relieve symptom of inflammatory bowel disease, and
attempt to lower colon cancer rates. The report draws atten
tion to the dilemma already noted in this paper that many of
the same effects are being promoted for ‘‘dietary fibres’’,
which raises the question of if and how prebiotics can be
differentiated from, or are they the same as, dietary fibres?
The FAO meeting put forward a definition for ‘‘prebiotics’’,
namely: ‘‘A prebiotic is a non-viable food component that
confers a health benefit on the host associated with modula-
tion of the microbiota’’. To make things even more confusing
they concluded also ‘‘A prebiotic can be a fibre but a fibre need
not be a prebiotic’’. Therefore there must be a method to
distinguish and decide what qualities constitute a prebiotic,
which raises practical and regulatory difficulties. The require-
ments which they identify are set out in Annex 1a and Fig. b1.
5. The position of probiotics
Another well publicised intervention in the ‘‘healthy food’’
category are the ‘‘Probiotics’’ (Steven et al., 2002) which seek to
ensure balanced microflora by introducing directly ‘‘colonic
foods’’ which claim to add to the amount of bacteria in the colon
termed ‘‘beneficial’’ so that they dominate over the potentially
harmful bacteria. It remains a controversial subject but the
concept is helpful in the overall dietary fibre context since it
stimulates research into the importance of microbial flora. The
value to health of these probiotic products now on the market
remains unproven. Stephen, Henry, Marks, and Short (2002)
identifies the following physiological role of microbial flora:
 fermentation and salvation of energy from nutrients
which are partly or totally resistant to digestion in the
upper gastrointestinal tract (stomach and small intestine);
 help in the absorption of vitamins and minerals;
 establishment of a barrier to protect the organism from
undesirable microbial invasion; and
 production of acetate, propionate and butyrate, the short
chain fatty acids that play key roles as modulators of cell
turnover and cell differentiation in the colonic mucosa
and which act also as regulators of the metabolism in
systemic tissues like the liver or even the muscle.
Materials which influence the behaviour of the microbial
population of the colon, therefore, have a basic health
interest. There is reason then to find a chemical definition
which when used directly implies that short chain fatty acids
are produced when passing into the colon. That could be the
reason why historically there seems to have been a desire to
encompass both concepts when defining dietary fibre: ‘‘Intrin-
sic cell wall polysaccharides’’ to give the chemical pedigree and
‘‘indigestibility in the small intestine’’ to convey a physiological
advantage (Englyst & Liu, 2007; Englyst, 2007). In any event a
claimed health effect needs to be proved rather than implied
by reference to the broad definitions.
6 Bioactive Carbohydrates and Dietary Fibre 1 (2013) 3 –9
Fig. b1 – Guidelines for evaluation.
Consideration too needs to be given to the influence of the
physical nature of the dietary carbohydrate on the physiolo-
gical behaviour. Jenkins et al. (1978) showed that viscosity
of the diet had an important action on the glucose responses
of non-starch polysaccharides.
6. Bioactive polysaccharides
There is also another carbohydrate designation now used which
again has the potential to overlap the material terminology
already referred to, namely ‘‘Bioactive Polysaccharides’’. Usually
derived from natural sources, these biomaterials are shown to
present specific biological activity (Phillips & Cui, 2011). Examples
are tea polysaccharides, mushroom sclerotial polysaccharides,
chitosan and chito-oligosaccharides, Artemis sphaerocephala
Krasch, Gum etc. These would not conventionally be classed as
‘‘dietary fibre’’ but offer possible health potential. Classically in
China, Japan and other Asian countries such materials are used
as traditional medicines. They offer a wealth of raw materials
from which specific active components can be identified. These
will require careful chemical characterisation to ensure that the
biological effects are reproducible. At this stage too it important
not to stray inadvertently into the health claim area from cell
culture observations. The subject has suffered from being
fragmented with chemical and biological observations often
again being presented in unrelated contexts.
The new Journal ‘‘Dietary Fibre and Bioactive Polysaccharides’’
offers a unique Forum which is currently not available where the
nature and behaviour of the material is given prominence in a
way that it has not been accorded previously. The subject has
suffered from being fragmented with chemical and biological
observations often being presented in unrelated contexts.
Usually the physiology aspects have taken preference over the
functional material’s molecular characteristics. In delivering
physical and technological performance such as texture control,
emulsification capability, gel formation etc of carbohydrate and
protein hydrocolloids, the structure-function relationships are
considered paramount and have been well studied. Likewise this
is now the challenge for bioactive polysaccharides, where it has
already been shown that conformation of a polysaccharide such
as lentinan has been shown to control its biological action.
7. What are the regulatory proven health
benefits of dietary fibre?
While there is an implied benefit when a dietary fibre can be
shown to convert into short chain fatty acids in the colon, it
must be noted again that this cannot be automatically converted
into a health claim. Literally several thousand health claims for
specific biomaterials have been presented to the European Food
Safety Agency (EFSA) Panel on Dietetic Products, Nutrition and
Allergies. Most have been rejected because in the opinion of
Panel there was insufficient evidence to justify the claim and this
despite much published information about their biological beha-
viour. An example is the EFSA Scientific Opinion relating to the
substantiation of health claims about acacia gum (gum arabic)
(EFSA, 2011). The first claim was for the maintenance of normal
blood cholesterol concentrations pursuant to Article 13(1) of
Regulation (EC) no. 1924/20061. The un-named applicants had
provided 10 references for the substantiation of the claimed
effect, three were general reviews on the effects of fibre on blood
lipids, one was on the metabolism of acacia gum and one was on
the effects of acacia gum on outcomes other than blood lipids.
All were reputable but relatively old literature references which
included a human study. Previously, within the general view in
the food industry, an implied cholesterol reduction effect had
been assumed for acacia gum, but the new EFSA regulations
makes it necessary for this ‘‘water-soluble type of fibre’’ to be
further scrutinised. The Panel considered ‘‘that no conclusions can
be drawn from these references in relation to the claimed effect’’. The
final conclusion was ‘‘that a cause and effect relationship has not
 Bioactive Carbohydrates and Dietary Fibre 1 (2013) 3 –9
been established between the consumption of acacia gum and main-
tenance of normal blood cholesterol concentrations.’’
Further separate claims for acacia gums were also sub-
mitted for decreasing potentially pathogenic gastro-intestinal
microorganisms (ID 758), changes in short chain fatty acid
(SCFA) production and pH in the gastro-intestinal tract (ID
759), changes in bowel function (ID 759), reduction of gastro-
intestinal discomfort (ID 759), maintenance of faecal nitrogen
content and/or normal blood urea concentrations (ID 840, 1975),
and maintenance of normal blood LDL–cholesterol concentra-
tions (ID 841) pursuant to Article 13(1) of Regulation (EC) no. 1924/
20061. All were rejected by the EFSA panel usually because the
cause and effects had not been established.
There is no disagreement about whether acacia gum is a
dietary fibre, and there is published information about its
physiological behaviour within the functions for which the
claims were made. Whereas the practitioners in the acacia field
have for a considerable time quoted these health claims by
referring to published data, EFSA has now ruled that they will
not allow a definite health claim to be made. Many probiotic
products came to the same fate at the hands of EFSA. Other
hydrocolloids dietary fibres have fared better than acacia gum.
The following health claims have been accepted:
Arabinoxylan Blood glucose EFSA journal
(from wheat level 2011;9(6):2205
germ)
Chitosan Blood cholesterol 2011;9(6)2214
level
Konjac Blood cholesterol 2009;7(9):1258
level
HPMC Blood cholesterol 2010;8(10)1739
and glucose levels
Pectin Blood cholesterol 2010;8(10)1747
and glucose levels
Resistant starch Blood glucose 2011;9(4):2022
There is need, therefore, for each particular dietary fibre to be
evaluated individually and the specific health benefit proven
before a commercial product can be offered. Consequently, there
is a dilemma between a desire to harness the health giving
properties of dietary fibre by giving healthy food to the public
and the legally permissible claims which can be made in relation
to the material. Indeed the very process that is intended to
protect the public may perversely prove an obstacle to this. It is
certainly not permissible to demonstrate or infer to the produc-
tion of short chain fatty acid production and point then to some
of the proven benefits of these materials. That is not to say that
there is not expert encouragement in this regard. Buttriss and
Stokes (2008) from the British Nutrition Foundation, London, UK
(2008) have provided authoritative information about the rela-
tionship between dietary fibre and health. They acknowledge
that ‘‘many studies have found that people on diets high in fibre have
reduced risks of certain diseases such as cancers, coronary heart disease,
obesity and possibly diabetes’’. They also support the point pre-
viously made ‘‘that reconciling chemical definitions for fibre with
definitions that reflect physiological effects remains a major challenge.’’
7
In this respect they quote the EFSA definition of dietary fibre as all non-
digestible carbohydrates plus lignin that comprises:
 non-starch polysaccharides—cellulose, hemicelluloses,
pectins, hydrocolloids (gums, mucilages, beta-glucans);
 resistant oligosaccharides—fructo-oligosaccharides (FOS),
galacto-oligosaccharides (GOS), other oligosaccharides that
resist digestion (with three or more monomeric units);
 resistant starch—physically enclosed starch, some types
of raw starch granules, retrograded amylose, chemically
and/or physically modified starches; and
 lignin naturally associated with dietary fibre polysaccharides.
‘‘Can we then promote such materials as healthy foods?’’
Buttriss and Stokes (2008), presumably giving the views of
the British Nutrition Foundation states that ‘‘People who eat
fibre-rich diets tend to have a reduced risk of certain cancers,
coronary heart disease (CHD) and obesity. Fibre can help to reduce
the energy density of foods owing to its bulking effect and can
promote satiety’’. Is this becoming close to advancing a health
claim? The UK government’s Scientific Advisory Committee
on Nutrition (SACN) 2008 has reviewed the role of dietary
carbohydrate in colorectal health (including colorectal can-
cer, irritable bowel syndrome and constipation),dietary car-
bohydrate and metabolic health[including insulin resistance,
glycaemic index (GI) and obesity. The data presented is
extremely useful since it comprehensively reviews the scien-
tific literature dealing with the relationship between dietary
fibre and disease. It is a vast reservoir of detailed information
which can prove an invaluable data base for researchers.
Each area needs an independent assessment before dietary
fibre–specific disease relationships can be identified.
Recently this has been undertaken for the relationship of
dietary fibre with colorectal cancer (Aune et al., 2011). The
authors searched PubMed and several other databases for
relevant studies up to December 2010. The results were carefully
statistically evaluated. The question which the study aimed to
answer was ‘‘Does a high intake of dietary fibre or whole grains
reduce the risk of developing colorectal cancer?’’ The British
Medical Journal considered this to be a landmark study and an
associated Editorial deserves consideration. They point to a
lesson which all associated with this subject need to take heed
of. Whereas food items rich in dietary fibre have been considered
since 1988 to prevent colorectal cancer, randomised trial study-
ing dietary fibre have not supported the association. Classical
nutritional epidemiology has consistently found that when a
food item is related to decreased incidence of disease and the
biological effect is attributed to a single component, when this
component is tested randomly the results are not what was
expected. The message is that researchers should study the
dietary source and not only one specific component. Aune and
colleagues have done this and showed that a high intake of fibre
from cereals and consumption of wholegrain foods is signifi-
cantly associated with a reduced risk of colorectal cancer
whereas no preventative effects can be seen with other sources
of dietary fibre. It is the whole grain and not the fibre component
alone that has the beneficial effects. It is not understood why
fibre from grains is associate with decreased risk when fibre
8 Bioactive Carbohydrates and Dietary Fibre 1 (2013) 3 –9
from fruit, for example, is not. The biological mechanisms to
account for this behaviour need to be further studied.
8. Medical intervention or regulation?
There is thus a clear need to balance medical experience of
the benefits of dietary fibre with the international–national
regulatory requirements, which are often slow and ineffec-
tive in their execution. The perceived benefit of dietary fibre
in chronic renal disease is a case in point. An important
recent evaluation brings into sharp focus how early dietary
intervention could assist the 16 million US adults with
chronic kidney disease (CKD) which is believe to be an
independent risk factor for cardiovascular disease.
Raj Krishnamurthy et al. (2012) analysed data from 14,543
participants in the National Health and Nutrition Examina-
tion Survey III. For each 10-g/day increase in total fibre intake,
the odds of elevated serum C-reactive protein levels were
decreased by 11% and 38%, in those without and with kidney
disease, respectively. Dietary total fibre intake was not sig-
nificantly associated with mortality in those without but was
inversely related to mortality in those with kidney disease.
Thus, their evidence indicated that a high dietary total fibre
intake is associated with lower risk of inflammation and
mortality in kidney disease
A commentary on these results (Evenepoel & Meijers, 2012)
provides support for possible intervention regimes arising from
these findings. They conclude that the harmful effects of CKD
are exacerbated by dietary protein and reversed by dietary fiber.
They further comment that ‘‘in the overall study population, it was
found that high fiber intake was associated with lower inflammation.
Although this association was found both in non-CKD and in CKD
patients, it was significantly stronger in CKD patients. Only in the
subgroup of patients with CKD, dietary fiber intake was also associated
with mortality risk. Each 10-g/ d increase in intake was associated with
a hazard ratio of 0.83 (total fiber), 0.77 (insoluble fiber), and 0.67
(soluble fiber) for overall mortality. This large population-based obser-
vational study thus suggests that the presence of CKD is a potent
modifier of the beneficial effects of dietary fiber intake’’.
In contrast to dietary fibre, dietary protein promotes pro-
teolytic fermentation, increases the nutritional acid load, and
is associated with poor outcomes in CKD. This potentially
explains why a ‘‘Mediterranean ‘‘diet protects against cardio-
vascular disease whereas a ‘‘Western’’ diet (characterised by a
high intake of processed meat, red meat, butter, high-fat dairy
products, and refined grains) confers an increased risk.
However, another conclusion of the commentary is ‘‘Prebiotics
are an attractive alternative to dietary fiber.’’ Thus after most
constructive observations the authors add a semantic confusion
to a major health observation and recommendation. Never-
theless, their overall conclusion is positive and clear ‘‘In conclu-
sion, the study of Krishnamurthy et al adds to a growing body of
evidence that dietary fiber has important health-promoting properties’’.
9. Conclusion
Despite the fact that a definition of dietary fibre, mainly based
on a chemical designation, has been legally accepted
internationally by Codex and in Europe by the European
Union, there remains some ambivalence to what extend the
chemical definition and the physiological action should be
given prominence. Conversion in the colon to short-chain
fatty acids is a necessary pre-requisite if the material is to be
considered a dietary fibre. While this might provide a health
aura to the product, it cannot be inferred that a specific health
benefit can be claimed. The route to a commercial product
bearing a specific health claim could require unequivocal
biological, physiological and clinical evidence coupled with
sound chemical characterisation of the test material. When a
natural product is shown to exhibit bioactivity and the
individual components responsible are tracked down, the
experience with whole grain foods needs to be built into the
investigation to assess the relative merits of the whole
material in relation to the component parts. Formulating a
healthy diet, in the final resort, should adopt a common sense
approach based on the emerging information on dietary fibre.
Annex 1a. FAO recommended method how to
evaluate and substantiate that a product is a
prebiotic
1. Product specification/characteristics of the prebiotic
The component to which the claim of being prebiotic is
attributed, must be characterised for any given product.
This includes:
 source, origin;
 Purity;
 chemical composition and structure; and
 vehicle, concentration and amount in which it is to be
delivered to the host.
2. Functionality
At a minimum, there needs to be evidence of a correlation
between the measurable physiological outcomes and
modulation of the microbiota at a specific site (primarily
the gastrointestinal tract, but potentially also other sites
such as vagina and skin). Need to correlate a specific
function at a specific site with the physiological effect and
its associated timeframe.
 Within a study, the target variable should change in a
statistically significant way and the change should be
biologically meaningful for the target group consistent
with the claim to be supported.
 Substantiation of a claim should be based on studies
with the final product type, tested in the target host.
 A suitably sized randomized control trial (compared to
placebo or a standard control substance) is required,
preferably with a second independent study.
 Examples of physiological outcomes due to administration
of prebiotics could be: satiety (measured towards carbohy-
drates, fats, total energy intake); endocrine mechanisms
regulating food intake and energy usage in the body;
effects on absorption of nutrients (e.g. calcium, magne-
sium, trace elements, protein); reduced incidence or
duration of infection; blood lipid and classic endocrine
parameters; bowel movement and regularity; markers for
cancer risk; changes in innate and acquired immunity
that are evidence of a health benefit.
 Bioactive Carbohydrates and Dietary Fibre 1 (2013) 3 –9
3. Qualifications
 Bifidogenic effects are not sufficient without demon-
strated physiological health benefits.
 It is recognised that at this time, determining events
that take place within compartments of the intestine
are often difficult. Until such times as specific site
sampling or more sophisticated methods can reliably
link microbiota modulation with health benefits, faecal
analysis will be deemed suitable, with limitations.
4. Safety
As with any food component, safety parameters are
established by all national regulations. It is recommended
that the following issues need to be covered in any safety
assessment of a prebiotic final product formulation:
 If, according to local legislation, the product has a
history of safe use in the target host, such as GRAS or
its equivalents, then it is suggested that further animal
and human toxicological studies may not be necessary.
 Safe consumption levels with minimal symptoms and
side effects should be established.
 The product must not contain contaminants and
impurities.
 Based upon current knowledge, the prebiotic should
not alter the microbiota in such a way as to have long
term detrimental effects on the host.
5. Management issues
 Production—the onus is on the manufacturer to ensure
substances considered prebiotics should have purity
and consistency in composition between product lots.
 Formulation and storage—It is recommended that the
limit of stability in different product types, effects of
processing and production technologies on prebiotic
composition, and the desired biological activity in the
target host be evaluated.
 Regulatory—Prebiotics are components designed for
specific health effects through modulation of the host
microbial population. The onus is on the producer to
provide the regulatory agency where sales are to be
made with an appropriate level of documentation
supporting the health claims. It is possible that these
may refer to disease prevention, treatment and risk
reduction claims. A number of documents available in
the public domain, such as PASSCLAIM, EFSA guide-
lines and others provide criteria for evaluating the
quality of data suitable for making health claims on
food and food components.
 The status of prebiotics is not established on an interna-
tional basis. The term prebiotic must be used only when a
health benefit related to modulation of the target site
microbiota has been demonstrated in the target host.
 The issues of product specific testing were considered.
The consensus was that the onus should be on the
producer to show that a new formulation e.g. yoghurt,
is equivalent to the one (e.g. dried powder) proven in
target host studies to confer the prebiotic effect.
6. Monitoring
The Technical Meeting recommends that prebiotic produ-
cers, medical professionals and public health officers
consider some form of system to monitor the health
outcomes of longterm prebiotic administration. This is
9
suggested as a means to gain insight into potential side
effects as well as assess long-term benefits. A necessary
prerequisite for surveillance is a proper trace-back system.
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