Clinical trial NCT01190358: Grape Seed Extract and Postprandial Oxidation and Inflammation
Official title: Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Modification of the postprandial inflammatory response.
timeFrame: 7 hours
Secondary outcomes:
measure: Metabolic response to a high fat meal.
timeFrame: 7 hours
Other outcomes:
Locations:
city: Davis
country: United States
facility: University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
state: California
city: Mather
country: United States
facility: VA Hospital, Mather
state: California
Study officials:
affiliation: University of California, Davis
name: Chulani T Kappagoda, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: