Grape Seed Extract and Postprandial Oxidation and Inflammation

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01190358
• Date of registration: 25/08/2010
• Primary sponsor: University of California, Davis
• Public title: Grape Seed Extract and Postprandial Oxidation and Inflammation GSEMetS
• Scientific title: Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
• Date of first enrolment: August 2010
• Target sample size: 12
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01190358
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Countries of recruitment

United States

Contacts

• Name: Chulani T Kappagoda, M.D., Ph. D.
• Affiliation: University of California, Davis

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Metabolic Syndrome

Intervention(s)

Dietary Supplement: Meganatural Gold®

Dietary Supplement: Placebo

Primary Outcome(s)

Modification of the postprandial inflammatory response. [Time Frame: 7 hours]

Secondary Outcome(s)

Metabolic response to a high fat meal. [Time Frame: 7 hours]

Secondary ID(s)

200917488

Source(s) of Monetary Support

Please refer to primary and secondary sponsors