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Completed

NCT Number: NCT01190358

Grape Seed Extract and Postprandial Oxidation and Inflammation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility), Davis, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Waist circumference of ≥ 40 inches (men) or ≥ 35 inches (women)
  • Elevated triglycerides ≥150mg/dl
  • HDL cholesterol of < 40mg/dl (men) or < 50mg/dl (women)
  • Elevated blood pressure of ≥ 130/85mmHg
  • 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.

Treatment and study plan

Placebo

Dietary Supplement

Sugar pill containing maltodextrin.

Other names: Placebo, non-active components

Grape seed extract

Dietary Supplement

Meganatural Gold® contains 300mg of grape seed extract.

Other names: Active, Meganatural Gold®

Primary outcomes

  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:

    • Serum lipids
    • Oxidized LDL
    • Hs-CRP
    • TNFα
    • IL1
    • IL6

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.

Acronym: GSEMetS

Important dates

Study start
2010
Primary completion
2011
Study completion
2015
First posted
Aug 27, 2010
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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