Grape Seed Extract and Postprandial Oxidation and Inflammation (GSEMetS)

• ClinicalTrials.gov Identifier: NCT01190358
• Recruitment Status: Completed
• First Posted: August 27, 2010
• Last Update Posted: July 19, 2017
• Sponsor: University of California, Davis
• Information provided by (Responsible Party): University of California, Davis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Metabolic Syndrome	Dietary Supplement: Placebo; Dietary Supplement: Grape seed extract	Not Applicable

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
• Actual Study Start Date: August 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Placebo; Sugar pill	Dietary Supplement: Placebo; Sugar pill containing maltodextrin.; Other Name: Placebo, non-active components
Active Comparator: Grape seed extract; 300mg of grape seed extract.	Dietary Supplement: Grape seed extract; Meganatural Gold® contains 300mg of grape seed extract.; Other Name: Active, Meganatural Gold®

Outcome Measures

Primary Outcome Measures :

1. Modification of the postprandial inflammatory response. [ Time Frame: 7 hours ]

   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:

   1. Serum lipids
   2. Oxidized LDL
   3. Hs-CRP
   4. TNFα
   5. IL1
   6. IL6

Secondary Outcome Measures :

1. Metabolic response to a high fat meal. [ Time Frame: 7 hours ]
   Assay for the insulin and glucose response generated from consumming a high fat meal (~40% of kcal from fat).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)

Davis, California, United States, 95616

VA Hospital, Mather

Mather, California, United States, 95655

Sponsors and Collaborators

University of California, Davis

Investigators

• Principal Investigator: Chulani T Kappagoda, M.D., Ph. D.; University of California, Davis

More Information

• Responsible Party: University of California, Davis
• ClinicalTrials.gov Identifier: NCT01190358
• Other Study ID Numbers: 200917488
• First Posted: August 27, 2010
• Last Update Posted: July 19, 2017
• Last Verified: July 2017

Additional relevant MeSH terms:

Grape Seed Extract; Metabolic Syndrome; Syndrome; Inflammation; Disease; Pathologic Processes; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents; Physiological Effects of Drugs