Grape Seed Extract and Postprandial Oxidation and Inflammation

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Grape seed extract

• Registration Number: NCT01190358
• Lead Sponsor: University of California, Davis

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-27
• Primary Completion: 2011-03
• Study Completion: 2015-09
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-17
• Last Update Posted: 2017-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Sugar pill
Grape seed extract	Grape seed extract	300mg of grape seed extract.

Primary Outcome Measures

Name	Time	Method
Modification of the postprandial inflammatory response.	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

Secondary Outcome Measures

Name	Time	Method
Metabolic response to a high fat meal.	7 hours	Assay for the insulin and glucose response generated from consumming a high fat meal (\~40% of kcal from fat).

Trial Locations

Locations (2)

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

VA Hospital, Mather; 🇺🇸 Mather, California, United States