NCT01244360

Brief Summary

The purpose of this study is to examine the effects of resveratrol on health and human performance. The study will evaluate cognitive function and several indicators of physical health before and after taking a resveratrol supplement or a placebo for three weeks.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

November 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 19, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

June 2, 2011

Status Verified

June 1, 2011

Enrollment Period

7 months

First QC Date

November 17, 2010

Last Update Submit

June 1, 2011

Conditions

Keywords

resveratrolinsulininflammationcognitionmetabolism

Outcome Measures

Primary Outcomes (1)

  • Vascular function

    vascular response to stress will be measured using flow mediated dilation and ultrasound.

    4 weeks, with option of additional 4 week treatment period

Secondary Outcomes (3)

  • Body fat percentage

    4 weeks, with optional additional 4 week treatment period

  • inflammation biomarkers

    4 weeks, with optional additional 4 week treatment period

  • cognitive function

    4 weeks, with optional additional 4 week treatment period

Study Arms (2)

Sugar Pill

PLACEBO COMPARATOR

Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.

Other: Placebo Comparator: Sugar Pill

Dietary Supplement: resveratrol

ACTIVE COMPARATOR

Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.

Dietary Supplement: resveratrol

Interventions

resveratrolDIETARY_SUPPLEMENT

Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.

Dietary Supplement: resveratrol

Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.

Sugar Pill

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men and women between 45 and 75 years of age
  • Normal heart rate and Blood pressure
  • Ability to use personal computer interface
  • Successful completion of physical activity readiness questionnaire

You may not qualify if:

  • Cardiovascular disease, uncontrolled hypertension, lung disease
  • inability to tolerate exercise
  • have taken grape related supplement in past 12 months
  • current use of drugs or dietary supplements to enhance exercise performance
  • allergy to wine, grape juice or grape seed supplements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marywood University

Scranton, Pennsylvania, 18509, United States

Location

MeSH Terms

Conditions

InflammationInsulin Resistance

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

StilbestrolsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolyphenolsPhenols

Study Officials

  • James Smoliga, Ph.D.

    Marywood University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2010

First Posted

November 19, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

June 2, 2011

Record last verified: 2011-06

Locations