Acute Effects of Grape Seed Extract on Insulin Sensitivity and Oxidative Stress and Inflammation Markers.

Completed · Not applicable · Has a placebo group

Conditions studied: Polyphenolic Compounds and Metabolism

In brief

The proposed study aims to investigate that consumption of grape seed extract (GSE) would improve antioxidant status and impaired insulin action following consumption of a pro-oxidative high carbohydrate, high fat (HCHF) meal in healthy human subjects.

Key facts

Study ID

NCT01995643

Run by

Clinical Nutrition Research Center, Illinois Institute of Technology

People needed

13

Starts

2013-10-01

Expected to finish

2014-08-30

Last updated by the study team

2021-07-27

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Aged between 20 to 65 years old
• Body Mass Index (BMI) range from 18.5 to 24.9 kg/m2; exception BMI 18.5 to 23 kg/m2 for Asian population
• Fasting blood glucose concentration < 110 mg/dL
• Fasting LDL-cholesterol <180 mg/dL
• Fasting Total cholesterol and Fasting Triglycerides < 250 mg/dL
• Weight stable: not gained or lost weight +/- 5 lbs in previous 3 months
• Non-smokers
• 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, i.e. lipid lowering medications, anti-inflammatory drugs, fish oil, probiotics, grape seed supplement, etc…If anti-inflammation and/or antibiotic medications/supplements are taken, subjects may qualify if go off these medications/supplements 30 days wash-out before entering the study.
• Able to provide informed consent
• Able to comply and perform the procedures requested by the protocol

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 ≥110 mg/dL
• Men and women who have uncontrolled blood pressure >140 mmHg/90 mmHg
• 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 are taking blood pressure lowering medication that may interfere the outcomes of the study; e.g. diuretics.
• 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.
• Men and women who are vegetarians or vegans
• Substance (alcohol or drug) abuse within the last 2 years.
• Excessive coffee and tea consumers (> 4 cups/day)
• Men and women who do excessive exercise regularly or athlete
• 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
• Women who are lactating

Where it is running

• Clinical Nutrition Research Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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