Diabetes Mellitus Clinical Trial
Official title:
Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes
The purpose of this study is to evaluate two levels of the herbal extract Salacia oblonga (salacinol) on postprandial glycemia and insulinemia in patients with Type 2 diabetes after ingestion of a high-carbohydrate control meal.
Although we have generated a good quantity of animal and human data on the salacinol
extract, we have not explored the effect of the salacinol extract on postprandial glycemia
or insulinemia in patients with type 2 diabetes.
We planned to study 66 patients with diabetes in this multicenter, randomized, double-blind,
three-treatment, crossover study. While in a fasted state, subjects were to consume one of
the following three meals: a standard liquid meal containing 110 g carbohydrate, 18 g
protein, 12 g fat, and 620 kilocalories (Control); Control plus 240 mg Salacia oblonga
extract; and Control plus 480 mg Salacia oblonga extract. Postprandial serum glucose and
serum insulin samples were to be analyzed for 180 min.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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