Grape Seed Extract and Postprandial Oxidation and Inflammation (GSEMetS)

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

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Grape seed extract

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Davis, California, United States, 95616
      • University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
    • Mather, California, United States, 95655
      • VA Hospital, Mather

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Sugar pill	Dietary supplement: Placebo; Sugar pill containing maltodextrin.; Other Names: 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 Names: Active, Meganatural Gold®

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 27, 2010

Study Record Updates

• Last Update Posted (Actual): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 17, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Inflammation; Metabolic Syndrome; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Phytogenic; Antioxidants; Grape Seed Extract
• Other Study ID Numbers: 200917488