Grape Seed Extract and Postprandial Oxidation and Inflammation (GSEMetS)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01190358 |
Recruitment Status :
Completed
First Posted : August 27, 2010
Last Update Posted : July 19, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metabolic Syndrome | Dietary Supplement: Placebo Dietary Supplement: Grape seed extract | Not Applicable |
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 |

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® |
- 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:
- Serum lipids
- Oxidized LDL
- Hs-CRP
- TNFα
- IL1
- IL6
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01190358
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 |
Principal Investigator: | Chulani T Kappagoda, M.D., Ph. D. | University of California, Davis |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT01190358 |
Other Study ID Numbers: |
200917488 |
First Posted: | August 27, 2010 Key Record Dates |
Last Update Posted: | July 19, 2017 |
Last Verified: | July 2017 |
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 |