Status:
COMPLETED
Dose-dependent Effect of Grape Seed Extract on Glucose Control in People With Impaired Glucose Tolerance
Lead Sponsor:
Clinical Nutrition Research Center, Illinois Institute of Technology
Conditions:
Impaired Glucose Tolerance
Eligibility:
All Genders
40-65 years
Phase:
NA
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 Description
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 toleranc...
Eligibility Criteria
Inclusion
- Aged between 40 to 65 years old male/female
- Body Mass Index (BMI) less than 35kg/m2
- Fasting blood sugar between 100-125 mg/dL
- Confirmed impaired glucose tolerance (IGT) upon 2 hr OGTT screening test (≥ 140 mg/dL \< 200mg/dL)
- Non-smoker
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications or dietary supplements that would interfere with outcomes of the study.
Exclusion
- Past smokers: abstinence for less than 2 years
- Men and women who smoke
- Men and women with known or suspected food intolerance, allergies or hypersensitivity to the study materials or closely related compound or any their stated ingredients.
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations ≥126 mg/dL
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
- Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
- Men and women who are taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplements, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
- Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Substance (alcohol or drug) abuse within the last 2 years.
- Excessive coffee and tea consumers (\> 4 cups/day)
- Unstable weight: gained or lost weight +/- 5 lbs in previous 3 months
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study and women who are lactating.
Key Trial Info
Start Date :
September 15 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2015
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02254317
Start Date
September 15 2014
End Date
July 1 2015
Last Update
January 28 2021
Active Locations (1)
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1
Eunyoung Park
Chicago, Illinois, United States, 60616