Effect of a Grape Seed Extract (GSE) on Insulin Resistance

NCT ID: NCT01889368

Last Updated: 2017-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-03-31

Brief Summary

In people with the metabolic syndrome, the investigators hypothesize that administration of a single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized LDL in the blood during a 24 hour period. These measurements will be assessed at hourly intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin resistance, oxidative stress, and the level of oxidized LDL in the blood.

Detailed Description

In people with the metabolic syndrome, the investigators hypothesize that administration of a single 300 mg dose of a grape seed extract (GSE) will reduce insulin resistance (how well cells in the body can take up and use glucose), oxidative stress, and the amount of oxidized LDL in the blood during a 24 hour period. Each of these can be elevated after eating high fat meals, which are commonly found in the average Western diet. To better assess the impact of these high fat eating patterns, three standardized high fat meals will be served during the study day: breakfast, lunch, and dinner. Measurements in the blood will be assessed at hourly intervals during the 24 hour study day protocol. Additionally, the investigators hypothesize that daily administration of 300 mg of GSE for 30 days will decrease baseline insulin resistance, oxidative stress, and the level of oxidized LDL in the blood when this 24 hour study day protocol is repeated and breakfast, lunch, and dinner are again served.

Insulin resistance will be measured using a comparison of insulin and glucose levels in the blood. Oxidative stress, a measure of inflammation, will be measured by cytokines levels in the blood. The level of oxidized LDL will be measured in the blood. The investigators also plan to undertake a subsidiary pharmacokinetic study on the various polymers which are known to be present in grape seed extracts to determine their bio-availability and their relationship to the biological effects observed.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Grape Seed Extract

This is a 30 day arm. At the baseline study visit, subjects will consume one 300 mg capsule of MegaNatural Gold followed by 3 high fat meals: breakfast, lunch, and dinner. Blood will be drawn at specified intervals throughout the day. Flow mediated dialysis will be performed before breakfast and again 1.5 hours later, after capsule consumption and breakfast. A minimum 14 day washout period will be between arms if this is the first arm in the randomized cross-over.

Group Type: ACTIVE_COMPARATOR

Grape Seed Extract

Intervention Type: DIETARY_SUPPLEMENT

300 mg capsule of Grape Seed Extract; 1 capsule will be consumed for an acute post-prandial study day and 1 capsule will be consumed daily for 30 days.

Placebo

This is a 30 day arm. At the baseline study visit, subjects will consume one placebo (maltodextrin) capsule followed by 3 high fat meals: breakfast, lunch, and dinner. Blood will be drawn at specified intervals throughout the day. Flow mediated dialysis will be performed before breakfast and again 1.5 hours later, after capsule consumption and breakfast. A minimum 14 day washout period will be between arms if this is the first arm in the randomized cross-over.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

300 mg capsule of maltodextrin; 1 capsule will be consumed for an acute post-prandial study day and 1 capsule will be consumed daily for 30 days.

Interventions

Grape Seed Extract

300 mg capsule of Grape Seed Extract; 1 capsule will be consumed for an acute post-prandial study day and 1 capsule will be consumed daily for 30 days.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

300 mg capsule of maltodextrin; 1 capsule will be consumed for an acute post-prandial study day and 1 capsule will be consumed daily for 30 days.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

MegaNatural Gold; Maltodextrin

Eligibility Criteria

Inclusion Criteria

• Metabolic Syndrome, based on subject meeting at least 3 of the following criteria:
• Abdominal obesity with waist circumference > 40 inches in men or > 35 inches in women,
• Pre-hypertension with blood pressure > 135/85,
• Fasting blood glucose levels above 110 mg/dl,
• Plasma triglyceride levels in excess of 150 mg/dl,
• HDL levels below 40 mg/dl in men or 50 mg/dl in women.

Exclusion Criteria

• Any known systemic disease,
• Diabetes,
• Alcohol consumption > 1-2 drinks/week,
• Taking any medications or supplements that will affect metabolism, their ability to exercise or oxidative status,
• Smokers,
• Female subjects having abnormal menstrual cycles, taking oral contraceptives, pregnant or lactating.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Illinois Institute of Technology

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chulani T Kappagoda, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

VA Hospital, Mather

Mather, California, United States

Countries

United States

Other Identifiers

329493-4

Identifier Type: OTHER

Identifier Source: secondary_id

329493

Identifier Type: -

Identifier Source: org_study_id