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Sponsored by: |
Ross Products |
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Information provided by: | Ross Products |
ClinicalTrials.gov Identifier: | NCT00306072 |
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.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus |
Drug: nutritional herbal extract from Salacia oblonga |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes |
Estimated Enrollment: | 82 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | September 2005 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Minnesota | |
Radiant Research | |
Edina, Minnesota, United States, 55435 | |
United States, Ohio | |
Radiant Research | |
Cincinnati, Ohio, United States, 45236 |
Study Director: | Jennifer A Williams, MPH | Ross Products Division of Abbott Laboratories |
Study ID Numbers: | CP-SRDB28 |
Study First Received: | March 20, 2006 |
Last Updated: | March 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00306072 History of Changes |
Health Authority: | United States: Institutional Review Board |
Metabolic Diseases Salacia Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |