Grape Seed Extract and Postprandial Oxidation and Inflammation
This trial is active, not recruiting.
|Treatments||placebo, meganatural gold®|
|Sponsor||University of California, Davis|
|Start date||August 2010|
|End date||March 2011|
|Trial size||12 participants|
|Trial identifier||NCT01190358, 200917488|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Intervention model||crossover assignment|
|Masking||single blind (subject)|
Modification of the postprandial inflammatory response.
time frame: 7 hours
Metabolic response to a high fat meal.
time frame: 7 hours
Male or female participants at least 18 years old.
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.
|Official title||Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.|
|Principal investigator||Chulani T Kappagoda, M.D., Ph. D.|
|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.|
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