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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by University of California, Davis
Sponsor:
Collaborator:
Illinois Institute of Technology
Information provided by (Responsible Party):
Chulani T. Kappagoda, M.D., University of California, Davis
ClinicalTrials.gov Identifier:
NCT01889368
First received: October 10, 2012
Last updated: June 25, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Dietary Supplement: Grape Seed Extract
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of a Grape Seed Extract (GSE) on Insulin Resistance

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • Changes in insulin resistance [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Changes in oxidized LDL (oxLDL) concentrations [ Time Frame: Baseline and 24 hour post-prandial response ] [ Designated as safety issue: No ]
    Changes in oxLDL concentrations will be assessed by ELISA methodology. Changes in the 24 hour post-prandial response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals.

  • Changes in oxidative stress [ Time Frame: Baseline and 24 hour post-prandial response ] [ Designated as safety issue: No ]
    Changes in the 24 hour post-prandial oxidative stress response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals. Changes in oxidative stress will be assessed by measuring cytokine production using ELISA methodology.

  • Changes in vascular stress [ Time Frame: Baseline and 1 hour post-prandial ] [ Designated as safety issue: No ]
    Changes in oxidative stress will be assessed by flow mediated dialysis (FMD). Changes will be assessed at baseline and one hour after capsule consumption and eating a high fat breakfast meal.

  • Changes in insulin response [ Time Frame: Baseline and 24 hour post-prandial response ] [ Designated as safety issue: No ]
    Changes in the 24 hour post-prandial insulin response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals.

  • Changes in oxidized LDL (oxLDL) concentrations [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: No ]
    Changes in oxLDL concentrations will be assessed by ELISA methodology. Changes in the 24 hour post-prandial response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals. The response from the baseline visit will be compared to the response obtained during the day 30 visit.

  • Changes in insulin response [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: No ]
    Changes in the 24 hour post-prandial insulin response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals. The response from the baseline visit will be compared to the response obtained during the day 30 visit.

  • Changes in oxidative stress [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: No ]
    Changes in the 24 hour post-prandial oxidative stress response will be assessed at one hour intervals during the post-prandial study days, after capsule consumption and eating 3 high fat meals. Changes in oxidative stress will be assessed by measuring cytokine production using ELISA methodology. The response from the baseline visit will be compared to the response obtained during the 30 day visit.

  • Changes in vascular stress [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: No ]
    Changes in oxidative stress will be assessed by flow mediated dialysis (FMD). Changes will be assessed at baseline and one hour after capsule consumption and eating a high fat breakfast meal. Results obtained during the first post-prandial study visit will be compared to those obtained 30 days later.


Estimated Enrollment: 12
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Dietary Supplement: 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.
Other Name: MegaNatural Gold
Placebo Comparator: 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.
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.
Other Name: Maltodextrin

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01889368

Contacts
Contact: Jody M Randolph, BA 530-752-7620 jmrandolph@ucdavis.edu

Locations
United States, California
VA Hospital, Mather Recruiting
Mather, California, United States, 95655
Contact: Laurie Vazquez, MSN, RN, FNP    916-843-9436      
Sponsors and Collaborators
University of California, Davis
Illinois Institute of Technology
Investigators
Principal Investigator: Chulani T Kappagoda, MD, PhD University of California, Davis
  More Information

No publications provided

Responsible Party: Chulani T. Kappagoda, M.D., Emeritus Professor of Medicine, University of California, Davis
ClinicalTrials.gov Identifier: NCT01889368     History of Changes
Other Study ID Numbers: 329493-4
Study First Received: October 10, 2012
Last Updated: June 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
Insulin resistance
Central adiposity
Elevated blood pressure
Vascular reactivity
Elevated triglycerides
Low high-density lipoprotein (HDL)

Additional relevant MeSH terms:
Insulin Resistance
Metabolic Syndrome X
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hyperinsulinism
Grape Seed Extract
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents

ClinicalTrials.gov processed this record on July 10, 2014