Clinical Trial: Dose-dependent Effect of Grape Seed Extract on Glucose Control in People With Impaired Glucose Tolerance
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: Dose-dependent Effect of Grape Seed Extract (GSE) on Glucose Control in People With Impaired Glucose Tolerance
Brief Summary: The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose control in people with impaired glucose tolerance (IGT).
Detailed Summary:
The proposed study is a single-center, placebo-controlled, randomized, 4-arm, crossover study that identify the lowest effective dose of GSE on glucose control in people with impaired glucose tolerance.
A planned sample size of 20 will be recruited into the study. This study will require one initial screening visit, pre-study visit, and 4 Oral Glucose Tolerance Test Days (OGTT) Days. This study will take 4-6weeks per subject to complete.
The trial will initiate with one screening visit, which will last for about 3-4 hours where the subjects' height, weight, BMI, waist circumference, fasting blood glucose, blood pressure and heart rate will be measured and a survey related to general eating, health and exercise habits will be completed. OGTT procedure will be performed to confirm IGT.
If willing and eligible to participate, a 3-day food record (2 weekdays and 1 weekend) will be given at the screening visit and collected on the following pre-study Visit to assess subject's baseline dietary intake and pattern. Also, subjects will be instructed to follow a relatively low polyphenolic-diet at least 7 days prior to the first OGTT Day and for the duration of the study. A dinner meal will be provided the day before the OGTT Day to control the second meal effect from food and beverage intake of the night before the OGTT Day.
Subjects will arrive at the center in a fasting state for at least 10 hours, well hydrated and rested. Each OGTT Day will require blood draws throughout the visit. After evaluation of subject's health status (via anthropometric, vital sign and blood glucose measurements and in-person interview), a registered nurse will place a catheter in subject's arm for the purpose of multiple blood sample collections and take
Sponsor: Institute for Food Safety and Health, United States
Current Primary Outcome: Changes in plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT) after administration of GSE capsules (containing 300mg, 600mg or 900mg Grape seed extract) compared to 0 mg placebo. [ Time Frame: 4 hr ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Institute for Food Safety and Health, United States
Dates:
Date Received: September 29, 2014
Date Started: September 2014
Date Completion: November 2017
Last Updated: February 6, 2017
Last Verified: February 2017
