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Grape Seed Extract and Postprandial Oxidation and Inflammation (GSEMetS)

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Placebo
Grape seed extract
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Grape seed extract

Arm Description

Sugar pill

300mg of grape seed extract.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).

Full Information

First Posted
August 25, 2010
Last Updated
July 17, 2017
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01190358
Brief Title
Grape Seed Extract and Postprandial Oxidation and Inflammation
Acronym
GSEMetS
Official Title
Grape Seed Extract and Postprandial Oxidation and Inflammation: A Pilot Study in People With the Metabolic Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2010 (Actual)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sugar pill
Arm Title
Grape seed extract
Arm Type
Active Comparator
Arm Description
300mg of grape seed extract.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo, non-active components
Intervention Description
Sugar pill containing maltodextrin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Grape seed extract
Other Intervention Name(s)
Active, Meganatural Gold®
Intervention Description
Meganatural Gold® contains 300mg of grape seed extract.
Primary Outcome Measure Information:
Title
Modification of the postprandial inflammatory response.
Description
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
Time Frame
7 hours
Secondary Outcome Measure Information:
Title
Metabolic response to a high fat meal.
Description
Assay for the insulin and glucose response generated from consumming a high fat meal (~40% of kcal from fat).
Time Frame
7 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chulani T Kappagoda, M.D., Ph. D.
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States
Facility Name
VA Hospital, Mather
City
Mather
State/Province
California
ZIP/Postal Code
95655
Country
United States

12. IPD Sharing Statement

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