Type 2 Diabetes Clinical Trial
Official title:
Therapeutic Trials of Low Glycemic Index Foods and Dietary Fiber in the Management of Diabetes, Hyperlipidemia and Renal Disease
Our objective was to test whether the highly viscous polysaccharide incorporated into the biscuit formulation would reduce the postprandial blood glucose response equally in healthy subjects and individuals with type 2 diabetes.
Despite significant achievements in treatment modalities and preventive measures, diabetes
has been increasing exponentially. Reduction in both fasting and prolonged postprandial
glycemia is of paramount importance in the disease prevention and the delay of diabetic
complications. Blood glucose concentration can be reduced by dietary means, and may be
influenced by factors such as type and amount of carbohydrate, nature of starch, quantity of
protein and fat, dietary fiber content, method of food processing, particle size and food
form. Glycemic index (GI) is a measure of the blood glucose-raising ability of the available
carbohydrate in foods. Although evidence is often insufficient and individual differences
occur, prospective studies and clinical trials have shown that low-GI diets may reduce the
risk of diabetes and improve glycemic control in diabetes.
High postprandial plasma glucose level can increase severity of diabetes and foods which
raise the blood glucose level least for a given carbohydrate content are most suitable for
individuals with type 2 diabetes. Lower postprandial glycemia is also important for healthy
subjects to prevent diabetes.
High fiber diets have been recommended for the general population and for the nutritional
management of patients with type 2 diabetes. Soluble dietary fiber retards digestion and
absorption of the associated dietary carbohydrate, thus flattening the postprandial rise in
plasma glucose and insulin concentrations. Some foods such as beta-glucan fiber containing
oats and barley, and soluble fibers isolates such as pectin, guar, psyllium, or glucomannan
have a high viscosity which gives them the greatest blood glucose lowering effect. Viscous
fibers, as a result of their rheological properties, form gel with the food and human
digesta and consequently reduce postprandial increases in plasma glucose concentrations in
both normal and diabetic subjects in positive relation to their level of viscosity.
Insoluble fibers such as cellulose and wheat bran have little effect.
The highly viscous polysaccharide (HVP) added to the study biscuit formulation is a blend of
highly viscous soluble fibers (polysaccharides) that act synergistically to develop a higher
level of viscosity than any other known dietary fiber in nature. One of the main components
of the HVP is glucomannan, a glucose-mannose polysaccharide obtained from grinding the tuber
root of Amorphophallus Konjac C. Koch, a plant that has been used as food and remedy for
thousands of years in the Far East. Highly refined glucomannan is 3 times more viscous than
guar and approximately 7 times more viscous than psyllium. The viscosity of the HVP is
amplified further with a viscosity 3-5 times higher than glucomannan alone used in
formulation, that is considered to be the highest viscosity single dietary fiber. Previously
we and others have shown that the higher viscosity in vitro directly corresponded to lower
blood glucose.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
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