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

NCT01995643 | Completed

• 1 other identifier: 2013-114
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Polyphenolic Compounds and Metabolism

Keywords

Grape seed extract; Polyphenols; Insulin; Oxidative stress Marker; Inflammatory marker; Healthy human

Outcome Measures

Primary Outcomes (1)

• Changes in insulin and glucose concentrations over 6 hours after the Grape Seed Extract Capsule administration

  The timing influence of the Grape Seed Extract administration on insulin and glucose concentrations in relative to the standard meal intake (1 hour before the meal and 5 hours after the meal)

  6 hours

Secondary Outcomes (1)

• Changes in oxidative stress markers and inflammatory markers over 6 hours after the Grape Seed Extract Capsule administration

  6 hours

Study Arms (2)

Active Capsule

ACTIVE COMPARATOR

Grape Seed Extract Capsule: 300 mg

Dietary Supplement: Active Capsule

Placebo Capsule

PLACEBO COMPARATOR

Placebo Capsule: Maltodextrin

Dietary Supplement: Placebo Capsule

Interventions

Active Capsule DIETARY_SUPPLEMENT

GSE Capsule

Active Capsule

Placebo Capsule DIETARY_SUPPLEMENT

Placebo Capsule

Placebo Capsule

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

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

Study Sites (1)

Clinical Nutrition Research Center

Chicago, Illinois, 60616, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Indika Edirisinghe, Ph.D

  Institute for Food Safety and Health

  PRINCIPAL INVESTIGATOR

• Britt Burton-Freeman, Ph.D, MS

  Institute for Food Safety and Health

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 30, 2014
• Last Updated: July 27, 2021

Record last verified: 2020-07

Locations

US (1)