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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
82
Radiant Research
Edina, Minnesota, United States
Radiant Research
Cincinnati, Ohio, United States
The primary variable to be measured was positive AUC (0-180 minutes) for plasma glucose.
The secondary variables to be measured were:
· Positive AUC (0 to 120 minutes) for plasma and serum glucose and positive AUC (0 to 180 minutes) for serum glucose
· Adjusted peak value for plasma and serum glucose
· Adjusted peak value for serum insulin
· Positive AUC 0-180 (0 to 120) minutes for serum insulin
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