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Grape Seed Extract and Postprandial Oxidation and Inflammation (GSEMetS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT01190358
First received: August 25, 2010
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention
Metabolic Syndrome
 Dietary Supplement: Placebo
Dietary Supplement: Meganatural Gold®

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Modification of the postprandial inflammatory response. [ Time Frame: 7 hours ] [ Designated as safety issue: No ]

    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:
  • Metabolic response to a high fat meal. [ Time Frame: 7 hours ] [ Designated as safety issue: No ]
    Assay for the insulin and glucose response generated from consumming a high fat meal (~40% of kcal from fat).


Estimated Enrollment: 12
Study Start Date: August 2010
Estimated Study Completion Date: June 2012
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill Dietary Supplement: Placebo
Sugar pill containing maltodextrin.
Other Name: Placebo, non-active components
Active Comparator: Grape seed extract Dietary Supplement: Meganatural Gold®
Meganatural Gold® contains 300mg of grape seed extract.
Other Name: Active, Meganatural Gold®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01190358

Locations
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
Investigators
Principal Investigator: Chulani T Kappagoda, M.D., Ph. D. University of California, Davis
  More Information

No publications provided

Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01190358     History of Changes
Other Study ID Numbers: 200917488
Study First Received: August 25, 2010
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 17, 2013