Back to resultsThe Effects of Resveratrol Supplementation on Measurements of Health and Human Performance (MUresv)
Primary Purpose
Inflammation
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
resveratrol
Placebo Comparator: Sugar Pill
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation focused on measuring resveratrol, insulin, inflammation, cognition, metabolism
Eligibility Criteria
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
Sites / Locations
- Marywood University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Sugar Pill
Dietary Supplement: resveratrol
Arm Description
Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.
Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.
Outcomes
Primary Outcome Measures
Vascular function
vascular response to stress will be measured using flow mediated dilation and ultrasound.
Secondary Outcome Measures
Body fat percentage
Body fat percentage will be measured using a DEXA scan.
inflammation biomarkers
Fasting blood draw
cognitive function
cognitive function will be assessed using a validated computer based assessment tool
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01244360
Brief Title
The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
Acronym
MUresv
Official Title
The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
June 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Marywood University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Measurements
blood laboratory parameters
cognitive assessment changes
body composition changes
vascular endothelial response
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
resveratrol, insulin, inflammation, cognition, metabolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Arm Description
Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.
Arm Title
Dietary Supplement: resveratrol
Arm Type
Active Comparator
Arm Description
Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.
Intervention Type
Dietary Supplement
Intervention Name(s)
resveratrol
Intervention Description
Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.
Intervention Type
Other
Intervention Name(s)
Placebo Comparator: Sugar Pill
Intervention Description
Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.
Primary Outcome Measure Information:
Title
Vascular function
Description
vascular response to stress will be measured using flow mediated dilation and ultrasound.
Time Frame
4 weeks, with option of additional 4 week treatment period
Secondary Outcome Measure Information:
Title
Body fat percentage
Description
Body fat percentage will be measured using a DEXA scan.
Time Frame
4 weeks, with optional additional 4 week treatment period
Title
inflammation biomarkers
Description
Fasting blood draw
Time Frame
4 weeks, with optional additional 4 week treatment period
Title
cognitive function
Description
cognitive function will be assessed using a validated computer based assessment tool
Time Frame
4 weeks, with optional additional 4 week treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Smoliga, Ph.D.
Organizational Affiliation
Marywood University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Marywood University
City
Scranton
State/Province
Pennsylvania
ZIP/Postal Code
18509
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
We'll reach out to this number within 24 hrs