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

NCT01889368 | Completed

• 2 other identifiers: 329493329493-4
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Keywords

Insulin resistance; Central adiposity; Elevated blood pressure; Vascular reactivity; Elevated triglycerides; Low high-density lipoprotein (HDL)

Outcome Measures

Primary Outcomes (1)

• Changes in insulin resistance

  Insulin resistance will be assessed by comparing the baseline fasting insulin concentration to the fasting insulin concentration after intervention period of 30 days; the Homeostatic Model Assessment (HOMA) value will be utilized for comparisons.

  Baseline and 30 days

Secondary Outcomes (8)

• Changes in oxidized LDL (oxLDL) concentrations

  Baseline and 24 hour post-prandial response

• Changes in oxidative stress

  Baseline and 24 hour post-prandial response

• Changes in vascular stress

  Baseline and 1 hour post-prandial

• Changes in insulin response

  Baseline and 24 hour post-prandial response

• Changes in oxidized LDL (oxLDL) concentrations

  Baseline and 30 days

Study Arms (2)

Grape Seed Extract

ACTIVE COMPARATOR

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.

Dietary Supplement: Grape Seed Extract

Placebo

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo

Interventions

Grape Seed Extract 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.

Also known as: MegaNatural Gold

Grape Seed Extract

Placebo 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.

Also known as: Maltodextrin

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead
• Illinois Institute of Technology: collaborator

Study Sites (1)

VA Hospital, Mather

Mather, California, 95655, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome; Insulin Resistance; Obesity, Abdominal; Hypertension; Hypertriglyceridemia

Interventions

Grape Seed Extract; maltodextrin

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Pharmaceutical Preparations

Study Officials

• Chulani T Kappagoda, MD, PhD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: June 28, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

US (1)