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In vivo effectiveness of a starch absorption blocker in a double-blind placebo- controlled study with normal college-age subjects

Joe A. Vinson, PhD and Donna M. Shuta, BS
Department of Chemistry
University of Scranton
Scranton, PA 18510

Inhibition of carbohydrate metabolism or absorption is one mechanism to reduce hyperglycemia in normal and especially in diabetic subjects. Another possible benefit is the decrease in calorie intake after eating carbohydrates for obesity and weight loss. In the 1980's there were several reports of in vitro and in vivo effectiveness of a natural starch blocker that worked by inactivating the enzyme amylase. We investigated this hypothesis with an initial pilot study. After this initial study with subjects who were physically active during the study, we did a second study to confirm the results. In this second study, again there was a double-blind placebo-controlled crossover trial with ten subjects (five males and five females aged 21 to 27) who participated with informed consent. After an overnight fast the subjects appeared in the morning and were given in a random fashion either 1) placebo consisting of 4 slices of white bread (60 g of carbohydrate), 42 g of soybean oil margarine, and 4 g of Sweet N'Low; 2) experimental comprising the control plus 1.5 g of Bio-Phase 2250™. The subjects rested between blood drawings. Plasma glucose was measured from blood sample drawn at baseline and every 15 minutes for 1 hour, then every 20 minutes for the second hour. Two subjects did not complete the study and 4 subjects were poor/non-absorbers as the area under the glucose-time curve was negative. Therefore the data of the remaining 4 subjects was used.

As expected the control bread produced an increase in glucose in the normal subjects that reached a broad peak after 45 minutes. The peak glucose for the Bio-Phase 2250™ group occurred at 30 minutes. This dose of Bio-Phase 2250™ produced a smaller increase than the control from 15 to 80 minutes, with an almost significant difference (p < 0.1) at 45 and 60 minutes. The glucose cleared from the plasma about 30 minutes earlier with the Bio-Phase 2250™ compared to the control. The area under the plasma glucose-time curve (a measure of glucose absorption and metabolism) was 85% lower with the Bio-Phase 2250™ , p < 0.05. Thus only 15% of the glucose in the bread compared to the control found its way into the body in the presence of Bio-Phase 2250™ . These results show the effectiveness of the product in decreasing the absorption of glucose from complex carbohydrates from this group of subjects.

Chart #1: Comparison of Bio-Phase 2250™ and Control on Change in Plasma                      Glucose in College-Age Subjects

Chart #2: Comparison of Bio-Phase 2250™ and Control on Change in Plasma                      Glucose in 11 Subjects