NCT01190358

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

7 months

First QC Date

August 25, 2010

Last Update Submit

July 17, 2017

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

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

    7 hours

Secondary Outcomes (1)

  • Metabolic response to a high fat meal.

    7 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Sugar pill

Dietary Supplement: Placebo

Grape seed extract

ACTIVE COMPARATOR

300mg of grape seed extract.

Dietary Supplement: Grape seed extract

Interventions

PlaceboDIETARY_SUPPLEMENT

Sugar pill containing maltodextrin.

Also known as: Placebo, non-active components
Placebo
Grape seed extractDIETARY_SUPPLEMENT

Meganatural Gold® contains 300mg of grape seed extract.

Also known as: Active, Meganatural Gold®
Grape seed extract

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Davis, California, 95616, United States

Location

VA Hospital, Mather

Mather, California, 95655, United States

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Grape Seed ExtractExercise

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex MixturesPharmaceutical PreparationsMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Chulani T Kappagoda, M.D., Ph. D.

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 27, 2010

Study Start

August 1, 2010

Primary Completion

March 1, 2011

Study Completion

September 1, 2015

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

US(2)