Grape Seed Extract and Postprandial Oxidation and Inflammation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-09-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo

Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Sugar pill containing maltodextrin.

Grape seed extract

300mg of grape seed extract.

Group Type ACTIVE_COMPARATOR

Grape seed extract

Intervention Type DIETARY_SUPPLEMENT

Meganatural Gold® contains 300mg of grape seed extract.

Interventions

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Placebo

Sugar pill containing maltodextrin.

Intervention Type DIETARY_SUPPLEMENT

Grape seed extract

Meganatural Gold® contains 300mg of grape seed extract.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo, non-active components Active, Meganatural Gold®

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No