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Ursula Erbacher

Final Report – Application Study

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Diabetes Application Study

The Effect of Regulat® Special Diat

Final Report Including Follow-Up Study

Ursula Erbacher October 15, 2009

Including Follow-Up Study Ursula Erbacher October 15, 2009 Author’s contact details: Ursula Erbacher Sudetenstr. 15

Author’s contact details:

Ursula Erbacher Sudetenstr. 15 61137 Schöneck, Germany Tel: 0 61 87/40 62 Fax: 0 61 87/40 61 E-mail: Ursula.Erbacher@medizinart.de

Table of contents:

1

Summary

4

2

Objective of the study

7

3

Method

7

4

Special characteristics and development

10

5

Survey results

10

6

Quantitative results/Test parameters

11

6.1 Blood sugar

14

6.2 Cholesterol

15

6.3 HDL-Cholesterol

15

6.4 LDL-Cholesterol

15

6.5

Triglyceride/Neutral fats

16

 

6.6 Insulin

17

 

6.7 Homocysteine

17

 

6.8 HbA1c

18

 

6.9 Adiponectin

18

6.10 Antioxidative capacity

19

6.11 Uric acids

19

6.12 Creatinine

20

 

6.13 SGPT

20

 

6.14 Gamma GT

21

6.15 Electrolytes:

21

7

Other results

21

 

7.1 Blood pressure results

21

 

7.2 Weight

22

 

7.3 BMI

22

7.4 Medical history

22

7.5 Digestive function issues

22

7.6 Nutritional issues

22

7.7 Additional medication

23

8

Observations and tolerance

23

9

Discussion points and further observations

23

Reference material:

25

Annex A: Quantitative Evaluation Questions Annex B: Quantitative Evaluation Test Results, Other Results Annex C: Status and Evaluation Participants Annex D: Data Sets Participants Annex E: Notes on Specific Test Parameters

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1 Summary This application study shows that the administration of Regulat® Special Diet (manufacturer Dr. Niedermaier Pharma, Hohenbrunn) results in regulation of the metabolic system in all parameters recorded with a remarkably strong trend towards the normal range. This key finding was apparent after just three months. After six months, further parameters moved into the normal range and the overall results stabilized. Evaluation of the survey of participants also revealed a significant improvement in their subjective sense of wellbeing.

A follow-up study carried out after a further three months confirmed the effect of the preparation. The results rose again for almost all participants who stopped taking Regulat® Special Diet after six months, but most were still clearly within the reference range. This proves the continued effectiveness of Regulat® Special Diet. The further improvement in test results is predominantly moderate, which, from the perspective of this study, means that treatment application should have both short and medium-term effects on the subject, which is positive and provides relief.

There was a clear stabilization of the results - and, to an extent, further improvement - in the three participants who continued taking the preparation. The result of this follow-up study is another indication of the effectiveness of the product. The following conclusion can be drawn:

sustained use of Regulat® Special Diet as a daily nutritional supplement would appear beneficial for diabetics and those at risk of diabetes.

Of a total of 221 test results recorded, 48 pathological results were determined in the preliminary study. After three months in the interim study only 25 were still in the pathological range and in the final study, only 17 – some marginal – out-of-range results were recorded. Only 8 results deviated from the upper reference values by more than 10%. In the preliminary study, 31 results were more than 10% outside of the upper reference threshold. In the follow- up study, a total of 17 results were more than 10% above the reference range. It should be noted that the remaining pathological results were mainly explained by the pathogenesis of individual participants. Overall, this underlines the constant regulatory and normalizing effect of the preparation, in particular with long-term use.

The effects on sleeping behavior and the digestive system were particularly noticeable. Of an initial 10 participants affected by sleeping disorders, only one still reported suffering from the condition in the follow-up study and the number of times she was waking up had improved from around 10 times per night initially to two or three times per night. The impact on the digestive system is also worthy of note. At the start of the study, eight participants complained of constipation and three of diarrhea. No participants complained of constipation or diarrhea in the follow-up study. They all reported a “good stomach condition” with less sensation of repletion and reduced flatulence. Other symptoms, such as back and joint pain or dysrhythmia, had either improved or no longer occurred.

The effect of Regulat® Special Diet is evident on both the hepatorenal and enterohepatic system. Homocysteine metabolism as a cardio-protective factor was positively influenced and there significant pancreatic hormonal relief was recorded thanks to the reductions in insulin, blood sugar and HBA1c. The impact of the ingredients cyanocobalamin, folic acids and pyridoxine had a significant effect on the development of the homocysteine results. Blood pressure also stabilized to within the normal range for all participants.

The vitality and concentration of participants, which initially increased by 37.5%, fell again in the follow-up study survey. The craving for sweet foods, which initially decreased significantly, now increased again. This also shows the regulatory effect on blood sugar and insulin.

The symptoms at the start of the study were diverse. At the end of the observational period, the complaints had been reduced significantly. Back pain, angina, digestive complains, paresthesia, tiredness and sensation of repletion disappeared to a large extent. The product appeared to have a regulatory effect on all of the statistics thanks to hepatorenal and enterohepatic relief. Significant subjective and objective improvements were clinically established in fatigue, anxiety and vitality. The participants were more agile, had more vitality and performed better. The taking of the test substance seemed to regulate, stabilize and enhance the organism.

The empirical data indicates that Regulat® Special Diet has an “immediate effect” and a “long- term” effect. After three months, the most significant changes were in blood sugar (fluoride),

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the triglycerides, insulin, homocysteine, adiponectin, uric acids, GGT and potassium. The effect on insulin and homocysteine continued in months 4 to 6, while the other results stabilized. Over a longer period of use, the most significant differences were evident in the cholesterol, LDL cholesterol, antioxidative capacity and SGPT parameters. The results after three months showed a clear trend towards regulation of the metabolic values, with the findings stabilizing after six months with a few pathogenic-related exceptions. The follow-up study substantiated these findings to an extent. A trend of a stronger re-increase towards the results of the preliminary study is evident in the parameters with an “immediate effect”.

During the test period, there were slightly contrary results in some parameters. The mean results initially improved after three months, and then rose again slightly after six months, but primarily within the reference range. This was evident in blood sugar, HDL cholesterol, HBA1c, antioxidative capacity, uric acids and GGT. In additional to statistical effects and daily physiological fluctuations of these metabolic parameters, habituation to the product may also be a factor, whereby the organism reduces the body’s own mechanisms owing to the metabolic shift. This needs to be examined in long-term studies.

Above all, the behavior of the vascular protective HDL cholesterol is noticeable in this respect. Despite the positive trend overall, these results fell in eight participants in the final study. In the follow-up study, the HDL cholesterol results increased again marginally. These results require further observation and investigation.

However, there was a clear trend in the LDL/HDL ratio: by taking Regulat® Special Diet, 12 of 13 participants reduced their ratio to an optimal level of < 3 and remained in this range in the follow-up study. All participants had a significantly better LDL/HDL ratio than at the beginning of the study and therefore achieved an improvement in cardio and vascular protective levels. This suggests that the preparation has a specific and sustained protective effect.

After stopping use of the test substance, the impact on the results was a move towards the initial trend. Pathological results determined outside of the reference range were only marginal. The body’s own self-regulation seemed to be stimulated. The following recommendations on administration can therefore be derived – sustained use is beneficial in cases of manifest conditions. At least alternating treatment is recommended in other cases. Recommendation: start by taking the preparation for six months, then stop use for three months, then take again for three months in cycles. The benefit of this is that the body’s own regulatory mechanism does not slacken off while individuals benefit from the positive effects of the nutritional supplement.

In summary, Regulat® Special Diet’s reputation as a regulatory product is fully justified.

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Effect of the preparation

Mean results

Effect of the preparation Mean results The$effect$of$Regulat ®

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2

Objective of the study

The application study aimed to examine the effect of Regulat® Special Diet based on 17 specific test parameters (metabolic functions, pancreatic hormone levels, parameters affecting vascular performance, electrolytes), a survey and various additional functional studies. The study is expected to provide a basis for understanding the preventative and stabilizing potential of the preparation.

The study was set up as a preliminary study. It involves broad-based recording of possible effects (also possibly side-effects) in a heterogeneous group of participants. Targeted studies with a high degree of significance with specific target groups can be carried out on the basis of this.

13 participants aged between 32 and 92 were chosen for this study (nine women and four men). These included two diagnosed diabetics, eight people suffering from obesity and five people of normal weight. A heterogeneous mixed group of participants was deliberately selected to obtain information that is as diverse as possible in this preliminary study. One participant dropped out after three months and one was unable to take part in the follow-up study.

3 Method

The study was carried out over nine months with a preliminary study, an interim study after three months, a final study after six months and a follow-up study after 3 months of stopping use. The participants were investigated, examined and surveyed objectively and subjectively. This report summarizes the results of the preliminary, interim, final and follow-up studies. Three participants continued taking the preparation over the entire nine months, while the other participants stopped taking the preparation at the final study stage, i.e. after six months. The group which stopped taking the preparation – as planned – after 6 months will subsequently be referred to as the “group that stopped use”, while those participants who continued to take Regulat are referred to as “the group that continued use”. As this group only consists of 3 people, two of whom were known diabetics, the statements on the “group that continued use” should only be interpreted as approximate guidelines.

Timeframe of the studies:

as approximate guidelines. Timeframe of the studies: The$effect$of$Regulat ®

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The following chemical test parameters were evaluated at the start of the study, and then again after three, six, and nine months as objective evaluation criteria:

Blood sugar glucose, Insulin, HbA1c, Adiponectin, Homocysteine, Antioxidative capacity, Overall cholesterol, HDL cholesterol, LDL cholesterol, Triglyceride, Uric acids, Creatinine, SGPT, SGGT, Sodium, Potassium, Calcium. Further explanatory notes on the specific test parameters are contained in Annex E. In addition to diabetes-specific and unspecific test parameters, the following parameters were also examined:

Blood pressure Weight BMI The following were recorded anamnestically:

Vitality, Craving for sweet foods, Thirstiness, Concentration, Sleep disorders, Constipation, Diarrhea and Obesity The following were examined anamnestically (including family history) Surveyed about diabetes type 1 or 2, Particular forms of nutrition (e.g. vegetarian, low-carbohydrate diet), Symptoms other medication. The following data was also recorded:

Clinical observations, Clinical impression, Assessment of the study leader, Assessment of the participants, Product acceptance.

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Blood samples were always taken on an empty stomach in the morning.

The preparation Regulat® Special Diet was administered in a dose of 2x10 milliliters daily every morning on an empty stomach and in the evening before going to sleep. The participants were required to insalivate sublingually for several minutes after taking the preparation.

The following reference ranges of the laboratory carrying out the tests were used for the evaluation of the quantitative data. The reference values for blood pressure were in line with common practice.

Test results Unit Reference range Basic results Blood sugar (fluoride) mg/dl 70 - 115 Cholesterol
Test results
Unit
Reference range
Basic results
Blood sugar (fluoride)
mg/dl
70 - 115
Cholesterol
mg/dl
< 240
HDL-Cholesterol
mg/dl
> 55
LDL-Cholesterol
mg/dl
< 150
Triglyceride
mg/dl
< 200
Insulin
mU/l
2.6-24.9
Homocysteine
mU/l
5 – 9.5
HbA1c
umol/l
4.6 – 6.5
Adiponectin
ug/ml
4 – 10
Antioxidative capacity
nmol/l
1.3 – 1.8
Additional results
Uric acids
mg/dl
3.4 - 7
Creatinine
mg/dl
0.5 – 1.1
SGPT
U/L
< 45
GGT
U/l
< 55
Sodium
nmol/l
135 - 148
Calcium
nmol/l
2.1 – 2.6
Potassium
nmol/l
3.6 – 5.3
Ferritin
ng/ml
34 - 310
Iron
ug/dl
59 - 158
Other results
Blood pressure, systolic
RR
110 - 130
Blood pressure, diastolic
RR
65 - 80
BMI
18.5 - 25

It should be noted at this point that only descriptive statistical values were recorded as part of this evaluation. The fact that a participant (VPN No. 11/PR) dropped out after three months was taken into account in the calculation of the mean changes.

Statistical test procedures and tests were not used as the study was designed as a preliminary study and not as a test of hypotheses. In particular, there were no results from a control group for statistical tests. This group would not have taken Regulat® Special Diet under comparable general conditions. It should also be noted when interpreting the results that the sub-results of the individual studies were shared with the participants as part of patient support. This information may have had an impact on the behavior of the participants and subsequent results.

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4

Special characteristics and development

In addition to the known type 2 diabetics, an additional four participants with borderline blood sugar levels and “noticeable” long-term blood sugar levels (HbA1c) of > 6.5% were determined in the preliminary study. As the reference values for non-diabetics are 4-6%, these four participants are clearly at risk of a diabetic illness.

The product was taken regularly in the prescribed dosage according to participant feedback. One participant said that she had only taken the product irregularly from the fifth month. Her results noticeably rose again in the pathological direction. In the case of this patient, it is worth noting that her results worsened again after nine months (cholesterol, LDL cholesterol, blood sugar, Gamma-GT). We nevertheless decided to include this patient in the statistical evaluation although we have referred to her results that stand out in some places.

In the case of one participant (PM), the insulin result could not be evaluated in the follow-up study. One participant (AB) could not take part in the follow-up study.

5 Survey results

The subjective assessment survey covered vitality, freshness, craving for sweet foods, thirstiness and concentration. There was a significant improvement in vitality from 44% after three months to 55.3% after six months. In the follow-up study, the vitality of the participants who continued to take the preparation remained high, while it declined among those who stopped taking the product.

The survey result on craving for sweet foods is also worthy of note. It fell by 18.2% on average after three months and by 40.5% after six months. Here too, there was an increase after participants stopped taking the test substance. It was evident that long-term use of the preparation not only regulated the objective test parameters, but also significantly regulated the subjective receptiveness to sweet foods. Among the participants where the craving for sweet foods grew initially, it fell after taking the preparation over a longer period. This is possibly explained by the metabolic shift achieved, habits and the sub-conscious mind. It clearly takes six months before a switch is achieved in terms of consciousness and metabolism.

The thirstiness of participants changed slightly. There was a clear improvement (37.5%) in subjectively assessed concentration among almost all participants after three months, whereas the improvement amounted to 43.6% on average after six months. With regard to concentration, a general improvement was recorded while the preparation was being taken and there was a fall in the follow-up study.

Mean results for preliminary, interim and final study:

Mean results for preliminary, interim and final study: See Annex A for details. The$effect$of$Regulat ®

See Annex A for details.

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6

Quantitative results/Test parameters

Ten specific test results were recorded on blood sugar balance, vascular status, oxygen supply, development of radicals and lipometabolism. In addition, seven test parameters were recorded on the hepatorenal system, metabolism and electrolytes. Blood pressure levels, body weight and BMI were also quantitatively evaluated.

The graphic clearly shows a significant reduction in results on average or a change towards the reference range overall. The individual results are examined below (N.B.: ferritin and iron results were only recorded for a few participants and are therefore not included in the mean result calculations).

Overviews are set out below:

Mean results of preliminary and final studies:

out below: Mean results of preliminary and final studies: The$effect$of$Regulat ®

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In the first three months, the most significant changes were in blood sugar (fluoride), triglycerides, insulin, homocysteine, adiponectin, uric acids, GGT and potassium. In months 4 to 6 of taking Regulat® Special Diet, the most significant changes were recorded in the insulin, homocysteine, cholesterol, LDL cholesterol, antioxidative capacity and SGPT parameters.

After 6 months, there were significant to very significant overall effects on: cholesterol, LDL cholesterol, Triglyceride, insulin, homocysteine, adiponectin, uric acids, creatinine, SGPT, GGT and potassium.

Only negligible effects were recorded for: HDL cholesterol (here slightly contrary), sodium and calcium.

Mean results from final and follow-up studies:

and calcium. Mean results from final and follow-up studies: In the follow-up study, after stopping use

In the follow-up study, after stopping use of the preparation, the trend reflected a decline in the results towards the level of the preliminary study nine months earlier. This trend was particularly prevalent amongst the “group that stopped use”. The following results only differ slightly from the results of the final study: blood sugar, HDL cholesterol, LDL cholesterol, insulin, homocysteine, creatinine, SGPT and GGT. The results for the “group that stopped use” fell to the level of the initial results for the test parameters of cholesterol, Triglyceride, adiponectin and uric acids. This indicates that the use of Regulat® Special Diet has a significant effect.

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In addition, there were also clear differences between the “group that stopped use” and “the group that continued use” in the follow-up study. There was a clear spread of mean results for cholesterol, LDL cholesterol, homocysteine and SGPT. This is a further indication of the effect of the preparation on metabolism.

Differentiation based on groups in the follow-up study:

Differentiation based on groups in the follow-up study: The development of antioxidative capacity is worthy of

The development of antioxidative capacity is worthy of note. This rose further in 10 of 11 participants in the follow-up study. The natural substances containing polyphenols unfold long- term action which may have a mitochondrial-protective effect and counter cell aging.

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Mean results of all tests:

Mean results of all tests: For individual results based on parameters and participants see Annex B

For individual results based on parameters and participants see Annex B and C. N.B.: The ID indications of the “group that continued use” are highlighted in brown in the following graphics.

6.1 Blood sugar

The blood sugar level stabilized in the optimal reference range for all participants. On average, the mean results were reduced by almost 6% from 90.4 to 86.1 mg/dl while taking the preparation. It is evident that most participants stabilized in the lower part of the reference range, i.e. approaching the normal definition of the 1980s. The blood sugar results of the “group that stopped use” fell again slightly in the follow-up study, while the mean result rose amongst the “group that continued use” which is explained by a very sharp rise in the case of participant DH (a diabetic).

It should be noted that the reference values for blood sugar are redefined annually as “healthy average people” are assessed and their mean results are established as reference values. The normal values of 20 years ago, for example, were significantly lower (between 60 and 80 mg/dl). This should be taken into account in evaluations.

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6.2 Cholesterol Overall cholesterol stabilized in the reference range for all participants with one exception.

6.2 Cholesterol

Overall cholesterol stabilized in the reference range for all participants with one exception. Participant SA only took the preparation on an irregular basis from week 20. There was an overall average change of 9.9% while the preparation was taken. After 9 months, the change was 11% amongst the “group that continued use” and 2.7% amongst the “group that stopped use”. Stopping the use of the preparation led to overall cholesterol rising again.

6.3 HDL Cholesterol

HDL cholesterol was below the reference range for many participants. There was a marginal reduction in fractional HDL cholesterol from 55.8mg/dl to 55.2 mg/dl. However, there were an additional eight results below the reference range in the final study. The results generally returned to the normal range in the follow-up study. The results of the group that continued use fell again slightly in the follow-up study, while the HDL level of the group that stopped use rose again slightly. With the reduction of overall cholesterol, the HDL fraction also clearly dropped when Regulat® Special Diet was taken. The long-term effect of the test substance requires further analysis. This is important because – according to studies – HDL cholesterol has a vascular protective effect.

6.4 LDL Cholesterol

The change in LDL cholesterol after six months is worthy of note. A significant improvement in lipometabolism only appears to be evident in long-term use. There was a marginal worsening of the LDL cholesterol fraction (+1.2%) after three months. However, the results improved by 13.7% on average after six months to 121.6 mg/dl. The results stabilized in the optimal range for all participants with one exception (marginal increase). This is also confirmed by the follow- up study the mean results of which can hardly be differentiated from the results of the final study. A slight rise was evident after the use of the preparation was stopped.

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6.5 Triglyceride/Neutral Fats The changes in the triglyceride study were drastic. All results were in the optimal reference range after three months and subsequently increased slightly. On average, there was a significant reduction of 17.6% after 6 months. Even in the follow-up study, constantly stable results in the reference range were recorded for all participants, whereby the “group that continued use” was 38.2% below the initial level. In the “group that stopped use”, the mean result increased again to almost the initial level.

Overall, we can conclude that the product had a significant impact on overall cholesterol, its sub-fraction LDL, and Triglyceride. An improvement in terms of vascular protective HDL cholesterol was not determined because this parameter also fell, which does not appear particularly beneficial in terms of vascular protection.

In this regard, a further point of interest is whether vascular protective HDL cholesterol increases with further use of the preparation in the long term. A clearer picture is determined through the LDL/HDL ratio as a risk factor. A LDL/HDL ratio under 3 is ideal. There is an increased risk of atherosclerosis and Alzheimer’s with a ratio of above 4.

atherosclerosis and Alzheimer’s with a ratio of above 4. By taking Regulat® Special Diet, all participants

By taking Regulat® Special Diet, all participants were able to reduce their ratio to an optimal result of < 3 in the follow-up study with one exception (92-year-old participant with arteriosclerosis and partial dementia). Seven participants even had a result of under 2.5. All participants had a significantly better ratio than at the start of the study. It can therefore be concluded that taking the product results in an improvement in terms of cardio and vascular protective effect. This suggests that the preparation has a specific and sustained protective action.

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6.6

Insulin

Significant improvements (50.3%) were recorded in the insulin level. There was a significant shift towards the reference range in the insulin results recorded for participants. After 6 months, there were only three participants with results which were below the reference range. After 9 months, the mean result stabilized to the low level of the final study.

mean result stabilized to the low level of the final study. 6.7 Homocysteine There was a

6.7 Homocysteine

There was a continuous decline in the homocysteine results of almost all participants while taking the preparation (overall by 30.1% on average). On average, there was a significant

by 30.1% on average). On average, there was a significant The$effect$of$Regulat ®

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normalization of the results by 4 mU/l from 12.4 mU/l to 8.5 mU/l. An improvement was notable over the entire duration of the study. This is presumably explained by the homocysteine-reducing ingredients of folic acids, cyanocobalamin and pyridoxin. In view of the damaging effect of homocysteine on cardiovascular activity and blood vessels, the reduction by a third represents an enormous improvement with regard to vascular activity and metabolism. A moderate rise was also recorded in the follow-up study.

A moderate rise was also recorded in the follow-up study. 6.8 HbA1c Regulat® Special Diet has

6.8 HbA1c Regulat® Special Diet has an effect on the long-term blood sugar value HbA1c. 11 participants reduced their results to an extent thanks to the product. The participants at risk of diabetes notably showed improved results. There was a slight increase in values in the follow- up study. The value increased by 0.6% for the male diabetic and remained at this level after six and nine months. However, he admitted that he still ate food that contained sugar. As his other results were normal, it remains to be seen how the result will develop in future. The participant felt much better after having taken the product, also in view of the fact that his neuropathic complaints were alleviated. The aim of modern diabetes treatment is to keep the HbA1c level below 6.5%, or even better under 6% to delay or avoid the long-term consequences of this illness for as long as possible. Type 2 diabetes cannot be ruled out even with an HbA1c level in the normal range. Generally, levels of over 6% support diagnosis. It was interesting to note that the HbA1c levels of all those at risk fell even after three months. After six and nine months, all HbA1 levels (except for one diabetic) were in the recommended or desired normal range.

6.9 Adiponectin The adiponectin levels climbed above the normal test range in some cases. However, as high adiponectin levels are believed to have a protective effect against cardiovascular diseases and diabetic metabolism, this should have resulted in improved metabolism at cell level with higher levels above the reference range having a positive effect.

levels above the reference range having a positive effect. The$effect$of$Regulat ®

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During use of the preparation, a stabilization in the reference range between 4 and 10ug/ml was recorded. In view of the fact that a low adiponectin level reduces the impact of the body’s own insulin, which means the blood sugar in the blood is not broken down, it is pleasing that so many participants were in the upper normal range after six months. With regard to genetic factors, a low adiponectin level increases the risk of diabetes and leads to vascular problems long before the discovery of diabetes. In the follow-up study period, the mean result rose, returning to the initial level.

6.10 Antioxidative capacity

All participants (with the exception of one 92-year-old man) showed normal results after six months. Taking into account the individual results of participants, it is evident that in the preliminary study lower values moved into the reference range as well as excessively high values. The product would also appear to have a regulatory effect in this respect.

also appear to have a regulatory effect in this respect. The antioxidative capacity of 10 of

The antioxidative capacity of 10 of 11 participants increased again – significantly in some cases – in the follow-up study period, in particular in participants who continued to take the substance (+40% compared to the initial level). It can therefore be assumed that the antioxidative capacity increases with the duration of the use of the preparation. The natural substances containing polyphenols clearly have an effect on the mitochondrial respiratory chain which combats cell aging.

6.11 Uric acids

Gratifyingly, the uric acids moved into the optimal reference range for all participants with one exception. This patient is now 92 years of age and does not like drinking. These findings of high uric acids and high creatinine have been recognized pathogenically for around 10 years in the case of this patient. On average, the result was reduced by 0.6 mg/dl in all participants in 6 months. That corresponds to 7.9%. The significant changes occurred in the first three months. The uric acids level subsequently rose slightly again in almost all participants.

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Considering there was no change in nutrition, the test substance is extremely useful in hepatorenal

Considering there was no change in nutrition, the test substance is extremely useful in hepatorenal metabolism relief. This is underlined by the results of the follow-up study: The “group that continued use” retained their level, while the results for the “group that stopped use” rose above the level of the preliminary study in some cases.

6.12 Creatinine

All results in the creatinine test were reduced to the reference range (except for the 92-year- old). In this case, the result did not change. On average, the results improved by 0.1 mg/l from 0.9 ng/dl to 0.8ng/dl. There was also an effect on hepatorenal metabolism here. The follow-up study confirmed the stable level.

6.13 SGPT

All pathologically increased results were stabilized within the normal range. Overall, there was a significant improvement of 24.2% while taking the preparation. It is evident that the main changes took place in the months 4 to 6. The effect of the product on hepatorenal metabolism was again evident. In the follow-up study, there were increases again in the SGPT results of the “group that continued use”, but these were still within the reference range, while the results fell slightly among the other participants.

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6.14 Gamma GT Optimization of results was recorded for all participants (except for one patient

6.14 Gamma GT

Optimization of results was recorded for all participants (except for one patient who, towards the end, took the product very irregularly). There was an overall 9.3% improvement in results on average. It was also evident here that the group which continued to take the preparation had more stable results than the group which stopped taking the product. There was also a significant impact here on the hepatorenal and enterohepatic system. This would indicate support for the detoxifying functions of the liver.

6.15 Electrolytes:

There was stabilization of pathologically increased potassium with an average overall improvement of 18.6% with all participants in the optimal range. The electrolytes sodium and calcium only changed marginally. It is evident that the pathologically increased potassium and sodium results were brought into the normal range. The results hardly changed after the interim study. The pattern was exactly the same in the follow-up study. The results constantly remained in the normal range after the product had been used.

7

Other results

7.1

Blood pressure levels

In blood pressure tests a pleasing trend towards stabilization within the normal range was recorded. On average, the results were systolically reduced from RR 131.2 to RR 121.3 while the preparation was used. There were diastolic reductions from RR 73.5 to RR 69.2. This corresponds to an improvement comparable with a moderate sporting activity (e.g. walking) of 3 x 20 minutes a week (Wendt 1998). Pleasingly, further stabilization was evident in the follow- up study.

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7.2

Weight

Weight was reduced by an average of 4.6 kilograms over 6 months. The weight of the “group that stopped use” increased again (by 0.5 kg on average) in the follow-up study period. However, the “group that continued use” achieved further weight loss (by 1 kg on average).

7.3 BMI

Nine people with a high BMI (Body Mass Index) took part in the study. BMI was also reduced thanks to the weight loss in all of these participants. BMI was reduced by 3.5% on average in the first six months. The effect was greatest in the first 3 months.

7.4 Medical history

Two participants had recognized type 2 diabetes, with corresponding medication, in their own medical history. As part of the preliminary study, we found four participants at risk of diabetes based on objective laboratory tests. After calculation of the results and regular use of the test substance, the risk of suffering from type 2 diabetes was reduced. After subsequent checking of the results – without usage – of the product, the participants with prediabetic elevated results (HBAIc, insulin, blood sugar) were pleasingly brought into the stable normal range. A study after a year would be useful here to establish whether the participants fall back into the prediabetic range without taking Regulat. With regard to family medical history, there was type 2 diabetes on the mother’s side in eight participants and on the father’s side in five participants.

7.5 Digestive function issues

At the beginning of the study, three participants were suffering from diarrhea and eight from constipation. After three months, bowel movement was normal in both patients with diarrhea, and those with constipation. This was also the case after six and nine months. All participants reported a significant improvement in stomach problems. Three participants reported a reoccurrence of a sensation of repletion after they stopped taking the substance. The regulatory effect of Regulat® Special Diet on digestive function was evident here.

7.6 Nutritional issues

Two vegetarians and one participant with a low-carbohydrate diet (approx. 60 to 80 gram/day) took part in the study. The symptoms at the start of the study were very diverse. The complaints had been significantly reduced by the end of the observation period. Back pain, angina, digestive complains, paresthesia, tiredness and sensation of repletion disappeared in most participants. The product seemed to have a regulatory effect on all statistics as there was clearly hepatorenal and enterohepatic relief. The reorganizational axes seemed to stabilize in the “fluid human system”, whereby rhythm and dynamism, as a basic principle of life with its transitions and changes, seemed to regulate, stabilize and enhance the organism after taking the test substance.

7.7 Additional medication

Around half of the participants continued to take their usual medication. One participant stopped taking the homocysteine-reducing vitamin product (Homocyvit) during the study. She had been diagnosed with hyperhomocysteinemia several years earlier. She had normal homocysteine levels at the start of the study.

8 Observations and tolerance

Significant clinical improvements were determined subjectively and objectively in exhaustion, anxiety and a lack of vitality. The participants had greater agility, vitality and better performance. Initial sleeping disorders disappeared after six and nine months.

The outstanding level of compliance, regular usage and high levels of motivation in the study are worthy of note. Only one participant took the product irregularly at the end upon request.

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The test substance was very well tolerated. There were no side-effects. Although one patient had a recognized intolerance to orange (eczema), no symptoms appeared. Several participants found the bitter taste unpleasant, while others found it to be tasty, in particular with newly opened bottles. The taste reminded them of cider. Although subjective approval increased significantly, some participants were pleased not to have to continue taking the bitter substance after six months. Even after 6 months, some considered the taste strange and said it took some getting used to.

One participant said that five warts on his hands completely disappeared after two months of taking the preparation. He had had these for around three years and they were becoming more prevalent. Whether this is a result of taking Regulat® Special Diet would need to be confirmed by further observations with the same efflorescence.

9 Discussion points and further observations

Regulat® Special Diet clearly has an effect on the hepatorenal and enterohepathic system. A current study is worthy of mention in this respect. Through a suitable angiogenesis/ vascomodel, the series of tests showed for the first time that the blood of patients with renal diseases has “anti-angiogene” properties. This means that the blood of these patients contains factors which restrict the generation of new blood vessels and results in a regression of already existing small blood vessels. Scientists succeeded in identifying a highly potent, anti-angiogene blood factor, the so-called “soluble VEGF-Receptor-1” (abbreviated as:

"sFlt-1"). This blood factor restricts the vascular protective and growth-stimulating VEGF ("Vascular Endothelial Growth Factor") found in the blood. Based on the polyphenol research on curcumin, we know that the Endothelial Growth Factor has an effect on the respiratory chain (Komplex4/5 (Aggarwal 2003). The fact that the natural product contains many polyphenols and curcumin may explain the hepatorenal effect.

Owing to the experience gained and the results produced, I believe that particular attention should be given to proinflammatory relationships in diabetes and prediabetes in further studies. Inflammatory parameters such as blood sedimentation, differential blood count, C- reactive protein sensitivity, interleukins, NFkB, TNFalpha, and TGFß could be examined for example.

Studies on LDH isoenzymes may also be worthwhile in view of mitochondriopathy as a precursor illness of type 2 diabetes or other illnesses. LDH4/5 increases and LDH1/2 reductions play a key role in mitochondrial performance weaknesses. The LDH isoenzymes 4 and 5 correlate with the LDH-A-genome, which activates or governs the glycolytic ATP synthesis and forms lactate as a waste product. Reduced oxidative energy formation begins here.

Long-term studies with food products from the range of ingredients of the natural product studied may be of interest in order to establish whether there is a difference between the taking of a cascade-fermented natural product and a natural food product.

With the exception of the electrolytes sodium and calcium, the parameters measured here would seem useful and meaningful for further studies. In various blood tests, it would be sufficient to only test adiponectin at the beginning and at the end. The inclusion of liver and kidney results would also be expedient as there are surprising effects here on the hepatorenal and enterohepatic system.

With a view to possible long-term usage, efforts should be made to improve the taste of the product or recommendations made for possible mixtures with other beverages.

Schöneck, October 15, 2009

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