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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01244360
Other study ID # MU Smoliga Resveratrol
Secondary ID 2RESMU194218
Status Active, not recruiting
Phase N/A
First received November 17, 2010
Last updated June 1, 2011
Start date November 2010
Est. completion date June 2011

Study information

Verified date June 2011
Source Marywood University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Measurements

- blood laboratory parameters

- cognitive assessment changes

- body composition changes

- vascular endothelial response


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 44
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years to 75 Years
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
resveratrol
Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.
Other:
Placebo Comparator: Sugar Pill
Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.

Locations

Country Name City State
United States Marywood University Scranton Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Marywood University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Body fat percentage Body fat percentage will be measured using a DEXA scan. 4 weeks, with optional additional 4 week treatment period No
Secondary inflammation biomarkers Fasting blood draw 4 weeks, with optional additional 4 week treatment period No
Secondary cognitive function cognitive function will be assessed using a validated computer based assessment tool 4 weeks, with optional additional 4 week treatment period No
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