Dose-dependent Effect of Grape Seed Extract on Glucose Control in People With Impaired Glucose Tolerance

Completed · Not applicable · Has a placebo group

Conditions studied: Impaired Glucose Tolerance

In brief

The objective is to identify the lowest effective dose of Grape Seed Extract (GSE) on glucose control in people with impaired glucose tolerance (IGT).

Key facts

Study ID

NCT02254317

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

16

Starts

2014-09-15

Expected to finish

2015-07-01

Last updated by the study team

2021-01-28

Who can join

Age: 40 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Eunyoung Park — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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