Overview

This trial is active, not recruiting.

Condition metabolic syndrome
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose prevention
Arm
(Placebo Comparator)
placebo Placebo, non-active components
Sugar pill containing maltodextrin.
(Active Comparator)
meganatural gold® Active, Meganatural Gold®
Meganatural Gold® contains 300mg of grape seed extract.

Primary Outcomes

Measure
Modification of the postprandial inflammatory response.
time frame: 7 hours

Secondary Outcomes

Measure
Metabolic response to a high fat meal.
time frame: 7 hours

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2012.
Information provided to ClinicalTrials.gov by University of California, Davis.