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Grape Seed Extract and Postprandial Oxidation and Inflammation (GSEMetS)

University of California (UC) Davis logo

University of California (UC) Davis

Status

Completed

Conditions

Metabolic Syndrome

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Grape seed extract

Study type

Interventional

Funder types

Other

Identifiers

NCT01190358
200917488

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

12 participants in 2 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Sugar pill
Treatment:
Dietary Supplement: Placebo
Grape seed extract
Active Comparator group
Description:
300mg of grape seed extract.
Treatment:
Dietary Supplement: Grape seed extract

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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