17. Before returning to baseline, a transient, barely noticeable postprandial hypoglycemic period can happen With high GI meals, the blood glucose curve shows a sharper rise, leading to an earlier peak in blood glucose In that case, postprandial hypoglycemia can be of greater magnitude and duration than in normal diet When low GI food is absorbed, glucose absorption occurs over a longer period of time and does not lead to postprandial hypoglycemia In normal conditions, blood glucose rises and returns to baseline after absorption of a standard meal 血糖與升糖指數 GI Time / hours Blood glucose 1 2 Hi GI Low GI Medium GI
47. Phase2 相關文獻 : 減重效果不佳 Weight loss not significant from placebo Trend in reduction of serum triglycerides 體重無明顯改變 Study 1: Significant reduction in postprandial glycemia (at t=60 min) 降低 66% 葡萄糖的吸收 , 60 分鐘後會產生飯後低血糖的情形 Study 2: No significant change in AUC or glycemia values GI not significant from control with any encapsulated product (even with 3000 mg). GI not significant from control for lower powder doses (1500 and 2000 mg), but significant for 3000 mg 3000mgGI 值才有顯著差異 Weight loss significantly greater than placebo 體重無明顯改變 Weight loss not significant from placebo 體重無明顯改變 Results 8 weeks Single use 6 single use 12 weeks 4 weeks Duration Powder mixed with meal Capsule or powder mixed with meal Soft chewable Capsule Form 1500 mg BID Study 1: 1500 mg Study 2: 750 mg 1500, 2000 or 3000 mg 1000 mg TID 1000 mg bid Dose RDBPC RDB crossover OL Crossover RDBPC RDBPC Design 50 obese Study 1: 11 healthy Study 2: 7 healthy 13 healthy 60 overweight 25 healthy n Udani (3) Vinson et al. Udani (2) Rothacker Udani Study
48.
Hinweis der Redaktion
Here is first the data that we have obtained in vitro on human alpha amylase and alpha glucosidase enzymes. As you can see, the inhibition of both enzymes by InSea2 occurs in a dose-dependant manner. Doses of 20 to 50 mg/L bring us close to complete inhibition with both enzymes. CLICK The IC 50 for alpha-amylase is below 3 mg/L and below 10 mg/L for alpha-glucosidase. The recommended dose for our product being 500 mg, you can see here that we are recommending an amount between 25 and 50 times the requirements for an effective blockage of both enzymes. At 500 mg, a gastric volume of 50 L would be required to reach doses equivalent to our IC50 for alpha-glucosidase. Of course, the volume of our stomach is greatly lower than that. CLICK Here, you have a clear demonstration of the first key benefit of InSea2. It can inhibit two key enzymes involved in starch degradation and assimilation.
Here you can see the blood glucose curve in its entirety, including the result after 30 minutes presented earlier. I am showing this for two purposes. First, the changes that we see in the blood glucose curves between placebo and InSea2 mimic what would be expected in shifting from a hi GI food to a low GI food. Glucose absorption occurs over a short period of time in the placebo curve whereas it spans as much as 3 hours in the InSea2 curve. CLICK Furthermore, we saw postprandial hypoglycaemia in the placebo curve, which also is a typical feature of hi GI foods. We see none of this in the InSea2 curve. CLICK In a nutshell, our data shows that InSea2 was able to change a high-GI food into a low-GI food, by inhibiting alpha-amylase and alpha-glucosidase. More importantly, these results were all obtained by using a dose which is similar to the recommended dose of 500mg. This result and the one shown on the preceding slide also support our third key feature for InSea2, stating that the product slows down insulin response and eliminates postprandial hypoglycaemia in vivo.
Here you can see the blood glucose curve in its entirety, including the result after 30 minutes presented earlier. I am showing this for two purposes. First, the changes that we see in the blood glucose curves between placebo and InSea2 mimic what would be expected in shifting from a hi GI food to a low GI food. Glucose absorption occurs over a short period of time in the placebo curve whereas it spans as much as 3 hours in the InSea2 curve. CLICK Furthermore, we saw postprandial hypoglycaemia in the placebo curve, which also is a typical feature of hi GI foods. We see none of this in the InSea2 curve. CLICK In a nutshell, our data shows that InSea2 was able to change a high-GI food into a low-GI food, by inhibiting alpha-amylase and alpha-glucosidase. More importantly, these results were all obtained by using a dose which is similar to the recommended dose of 500mg. This result and the one shown on the preceding slide also support our third key feature for InSea2, stating that the product slows down insulin response and eliminates postprandial hypoglycaemia in vivo.