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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
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Tracking Information
First Submitted Date  ICMJE August 25, 2010
First Posted Date  ICMJE August 27, 2010
Last Update Posted Date July 19, 2017
Actual Study Start Date  ICMJE August 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2010)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Grape Seed Extract and Postprandial Oxidation and Inflammation
Official Title  ICMJE Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Dietary Supplement: Placebo
    Sugar pill containing maltodextrin.
    Other Name: Placebo, non-active components
  • Dietary Supplement: Grape seed extract
    Meganatural Gold® contains 300mg of grape seed extract.
    Other Name: Active, Meganatural Gold®
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Sugar pill
    Intervention: Dietary Supplement: Placebo
  • Active Comparator: Grape seed extract
    300mg of grape seed extract.
    Intervention: Dietary Supplement: Grape seed extract
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2010)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01190358
Other Study ID Numbers  ICMJE 200917488
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of California, Davis
Study Sponsor  ICMJE University of California, Davis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chulani T Kappagoda, M.D., Ph. D. University of California, Davis
PRS Account University of California, Davis
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP