Status:
COMPLETED
Grape Seed Extract and Postprandial Oxidation and Inflammation
Lead Sponsor:
University of California, Davis
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01190358
Start Date
August 1 2010
End Date
September 1 2015
Last Update
July 19 2017
Active Locations (2)
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1
University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
Davis, California, United States, 95616
2
VA Hospital, Mather
Mather, California, United States, 95655