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Clinical Study : USA

Study Design:

Fourteen type 2 diabetes patients (7 men and 7 women) ranging in age from 34 to 68 years were selected for the study. Patients with clinically evident kidney, liver, heart or neurological conditions were excluded from the study sample. In addition, pregnancy, lactation, a history of alcohol or other drug abuse, and allergies to spices or any of the ingredients of the nutritional bar were the exclusion criteria for the study.

The subjects who fulfilled the study's criteria were asked to sign an info rmed consent form. All participants were put on 1 diabetic bar, after meal (breakfast, lunch, and dinner). The subjects were provided a 4-week supply of diabetic bars at the onset of the study and at each visit scheduled on weeks 4 and 8. All subjects participating in the study were given the same healthy diet and life style instructions and were told to continue their usual physical activity.

The clinical and laboratory evaluation time-points on week 0, 4 and 8 included the following clinical and laboratory parameters of safety and efficacy of nutritional intervention.

•  Body weight
•  Vital signs,
•  Self-assessment of appetite levels
•  Clinical biochemistry.

Appetite levels were evaluated based on the following scale: 0 - not hungry, 1 - somewhat hungry, 2 - hungry, 3 - very hungry, 4 - extremely hungry.

The clinical biochemistry of the participants was evaluated at the onset of trial and at completion of trial. of the trial and included fasting blood glucose levels and levels of glycosylated hemoglobin (HbA1c).

Results:

  Six women and four men completed the study.

The weight loss results with the nutritional bar treatment could be explained, to some degree, by the fact that most of the patients ate less due to decreased cravings for food. The appetite lowering effect of the treatment had a tendency to hold after the initial four and then 8 week regimen.

The blood chemistry data indicate that regular consumption of three bars per day resulted in gradual decline in blood fasting glucose levels and levels of glycosylated hemoglobin.

Minimal side effects:

Some patients who completed 8 week regimen noticed that they developed transient gas and loose stool, which symptoms were alleviated by temporary altering of the prescribed study regimen, e.g. skipping the bar or eating it at different time of the day.

The consensus among participants of the study was that the bar is convenient and effective nutritional intervention which improves the quality of life for a patient suffering from NIDDM .

Source: Badmaev, V, Majeed, M., Prakash, L. and Cooper, JT. Open field, physician controlled evaluation of nutritional bar in management of non-insulin dependent diabetes mellitus (NIDDM). Nutracos Sept-Oct 2003, 29-32.

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