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Grape Seed Extract and Postprandial Oxidation and Inflammation (GSEMetS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01190358
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : July 19, 2017
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Placebo Dietary Supplement: Grape seed extract Not Applicable

Detailed Description:
The purpose of this study is to determine whether taking grape seed extract prior to eating a high fat meal will reduce the inflammatory response in people with the metabolic syndrome. If this extract is shown to mitigate the inflammatory response induced by a high fat meal, it could potentially aid in postponing of the diagnosis of diabetes or other chronic diseases associated with high levels of inflammation.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
Actual Study Start Date : August 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Placebo
Sugar pill
Dietary Supplement: Placebo
Sugar pill containing maltodextrin.
Other Name: Placebo, non-active components

Active Comparator: Grape seed extract
300mg of grape seed extract.
Dietary Supplement: Grape seed extract
Meganatural Gold® contains 300mg of grape seed extract.
Other Name: Active, Meganatural Gold®

Primary Outcome Measures :
  1. Modification of the postprandial inflammatory response. [ Time Frame: 7 hours ]

    Analysis of inflammatory markers known to increase following a meal high in fat (~40% kcal from fat). Markers to be analyzed will include the following:

    1. Serum lipids
    2. Oxidized LDL
    3. Hs-CRP
    4. TNFα
    5. IL1
    6. IL6

Secondary Outcome Measures :
  1. Metabolic response to a high fat meal. [ Time Frame: 7 hours ]
    Assay for the insulin and glucose response generated from consumming a high fat meal (~40% of kcal from fat).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

The metabolic syndrome will be diagnosed on the basis of having a combination of any 3 of the following factors:

  1. Waist circumference of ≥ 40 inches (men) or ≥ 35 inches (women)
  2. Elevated triglycerides ≥150mg/dl
  3. HDL cholesterol of < 40mg/dl (men) or < 50mg/dl (women)
  4. Elevated blood pressure of ≥ 130/85mmHg
  5. Fasting glucose of > 100mg/dL

Exclusion criteria:

  • Smokers
  • Female subjects who are pregnant or lactating
  • Subjects taking any medications that would interfere with outcomes of the study i.e. lipid lowering medications, anti-inflammatory drugs (i.e. ibuprofen), dietary supplements
  • Subjects with any known allergy or intolerance to foods involved in the study (cantaloupe, egg, dairy, wheat, grape seed extract)
  • Subjects who are actively trying to lose weight
  • Subjects with unusual dietary habits (i.e. pica, anorexia nervosa, extreme food restriction, binging and/or purging disorders)
  • Subjects who are addicted to drugs or alcohol or who are <1 year recovery program
  • Subjects who present with significant psychiatric or neurological disturbances as determined by the primary investigator (i.e. uncontrolled bipolar disorder)
  • Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension (≥ 140/90mmHg), liver and kidney disease as identified by routine blood tests (chemistry panels). These subjects will be referred to their primary care doctor for further care.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190358

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United States, California
University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
Davis, California, United States, 95616
VA Hospital, Mather
Mather, California, United States, 95655
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Chulani T Kappagoda, M.D., Ph. D. University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01190358    
Other Study ID Numbers: 200917488
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Additional relevant MeSH terms:
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Grape Seed Extract
Metabolic Syndrome
Pathologic Processes
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs