Grape Seed Extract and Postprandial Oxidation and Inflammation

Metabolic Syndrome Clinical Trial

— GSEMetS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01190358
• Other study ID #: 200917488
• Status: Completed
• Phase: N/A
• First received: August 25, 2010
• Last updated: July 17, 2017
• Start date: August 2010
• Est. completion date: September 2015

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2015
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Dietary Supplement:
• Placebo
Sugar pill containing maltodextrin.
• Grape seed extract
Meganatural Gold® contains 300mg of grape seed extract.

Locations

Country	Name	City	State
United States	University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)	Davis	California
United States	VA Hospital, Mather	Mather	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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; TNFa; IL1; IL6	7 hours
Secondary	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