Grape Seed Extract and Postprandial Oxidation and Inflammation

Study Overview
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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.

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.

Official Title
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Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Grape seed extract


Participation Criteria
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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: Waist circumference of ≥ 40 inches (men) or ≥ 35 inches (women) Elevated triglycerides ≥150mg/dl HDL cholesterol of < 40mg/dl (men) or < 50mg/dl (women) Elevated blood pressure of ≥ 130/85mmHg 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Sugar pill | Dietary Supplement: Placebo<br>* Sugar pill containing maltodextrin.<br>* Other names: Placebo, non-active components;|
| Active Comparator: Grape seed extract<br>300mg of grape seed extract. | Dietary Supplement: Grape seed extract<br>* Meganatural Gold® contains 300mg of grape seed extract.<br>* Other names: Active, Meganatural Gold®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of the postprandial inflammatory response. | 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: Serum lipids Oxidized LDL Hs-CRP TNFα IL1 IL6 | 7 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic response to a high fat meal. | Assay for the insulin and glucose response generated from consumming a high fat meal ( 40% of kcal from fat). | 7 hours |