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

NCT02254317 | Completed

• 1 other identifier: 2014-074
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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).

Conditions

Impaired Glucose Tolerance

Keywords

Impaired Glucose Tolerance; Oral Glucose Tolerance Test; Grape Seed Extract

Outcome Measures

Primary Outcomes (1)

• 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.

  plasma metabolic markers over 4 hour Oral Glucose Tolerance Test (OGTT)

  4 hr

Study Arms (4)

0 mg placebo

PLACEBO COMPARATOR

Not containing GSE (Placebo)

Dietary Supplement: 0 mg placebo

300 mg GSE

ACTIVE COMPARATOR

Containing 300 mg of GSE

Dietary Supplement: 300 mg GSE

600 mg GSE

ACTIVE COMPARATOR

Containing 600 mg of GSE

Dietary Supplement: 600 mg GSE

900 mg GSE

ACTIVE COMPARATOR

Containing 900 mg of GSE

Dietary Supplement: 900 mg GSE

Interventions

0 mg placebo DIETARY_SUPPLEMENT

Not containing GSE (Placebo)

Also known as: Placebo Comparator

0 mg placebo

300 mg GSE DIETARY_SUPPLEMENT

300 mg GSE

Also known as: Active Comparator1

300 mg GSE

600 mg GSE DIETARY_SUPPLEMENT

Containing 600 mg of GSE

Also known as: Active Comparator2

600 mg GSE

900 mg GSE DIETARY_SUPPLEMENT

Containing 900 mg of GSE

Also known as: Active Comparator3

900 mg GSE

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Eunyoung Park

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Britt Burton-Freeman, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: October 1, 2014
• Study Start: September 15, 2014
• Primary Completion: June 27, 2015
• Study Completion: July 1, 2015
• Last Updated: January 28, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)