- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01244360
The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance (MUresv)
June 1, 2011 updated by: Marywood University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Measurements
- blood laboratory parameters
- cognitive assessment changes
- body composition changes
- vascular endothelial response
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Scranton, Pennsylvania, United States, 18509
- Marywood University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Sugar Pill
Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.
|
Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.
|
|
Active Comparator: Dietary Supplement: resveratrol
Subject will take resveratrol supplement 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vascular function
Time Frame: 4 weeks, with option of additional 4 week treatment period
|
vascular response to stress will be measured using flow mediated dilation and ultrasound.
|
4 weeks, with option of additional 4 week treatment period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body fat percentage
Time Frame: 4 weeks, with optional additional 4 week treatment period
|
Body fat percentage will be measured using a DEXA scan.
|
4 weeks, with optional additional 4 week treatment period
|
|
inflammation biomarkers
Time Frame: 4 weeks, with optional additional 4 week treatment period
|
Fasting blood draw
|
4 weeks, with optional additional 4 week treatment period
|
|
cognitive function
Time Frame: 4 weeks, with optional additional 4 week treatment period
|
cognitive function will be assessed using a validated computer based assessment tool
|
4 weeks, with optional additional 4 week treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Smoliga, Ph.D., Marywood University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Anticipated)
June 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
November 17, 2010
First Submitted That Met QC Criteria
November 18, 2010
First Posted (Estimate)
November 19, 2010
Study Record Updates
Last Update Posted (Estimate)
June 2, 2011
Last Update Submitted That Met QC Criteria
June 1, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU Smoliga Resveratrol
- 2RESMU194218 (Other Identifier: Marywood University)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Inflammation
-
University of EdinburghUmeå UniversityCompletedSystemic Inflammation | Respiratory InflammationSweden
-
University of AarhusAarhus University Hospital; University of CopenhagenCompletedSystemic Inflammation | Airway InflammationDenmark
-
Sykehuset TelemarkRikshospitalet University Hospital; Helse Sor-OstCompletedAirway Inflammation | Peripheral Blood Inflammation Markers | Cement Dust ExposureNorway
-
Center for Research and Innovation Viña Concha...Universidad Católica del MauleNot yet recruitingInflammaging | Antioxidant Status, Inflammation | Inflammation Biomarkers | Antioxidant Capabilities | Cardiometabolic Health IndicatorsChile
-
University of NebraskaRecruiting
-
Central Hospital, Nancy, FranceRecruiting
-
Oral Science International Inc.AdvarraNot yet recruiting
-
University of NebraskaCompletedPeriodontal InflammationUnited States
-
University of California, DavisCompleted
-
Università degli Studi di BresciaCompletedVitreous Inflammation
Clinical Trials on Placebo Comparator: Sugar Pill
-
Massachusetts General HospitalGaneden Biotech, Inc.TerminatedIrritable Bowel Syndrome | Major Depressive DisorderUnited States
-
University of California, Los AngelesCompletedAutism Spectrum DisorderUnited States
-
Louisiana State University Health Sciences Center...National Multiple Sclerosis SocietyWithdrawnMultiple SclerosisUnited States
-
Ohio State UniversityNovartisTerminated
-
University of UtahUnited States Department of DefenseTerminated
-
Queen's UniversityMerck Sharp & Dohme LLCCompletedAllergic RhinoconjunctivitisCanada
-
University of MiamiCellHealth InstituteCompleted
-
SunovionCompletedAlzheimer's DiseaseUnited States
-
Johns Hopkins UniversityCompletedEmphysema | COPD | Chronic Bronchitis
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Himalaya...CompletedCystinuria | Nephrolithiasis, Calcium OxalateUnited States