Ignite Creation Date:
2024-05-05 @ 4:45 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306072
Status:
COMPLETED
Last Update Posted:
2010-01-27
First Post:
2006-03-20
Brief Title:
Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes
Sponsor:
Ross Products
Organization:
Ross Products
Study Overview
Official Title:
Effect of Different Doses of Salacinol Extract on Glycemic and Insulinemic Response in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None