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The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance (MUresv)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Marywood University
ClinicalTrials.gov Identifier:
NCT01244360
First received: November 17, 2010
Last updated: June 1, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention
Inflammation
 Dietary Supplement: resveratrol
Other: Placebo Comparator: Sugar Pill

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance

Resource links provided by NLM:

Drug Information available for: Resveratrol
U.S. FDA Resources

Further study details as provided by Marywood University:

Primary Outcome Measures:
  • Vascular function [ Time Frame: 4 weeks, with option of additional 4 week treatment period ] [ Designated as safety issue: No ]
    vascular response to stress will be measured using flow mediated dilation and ultrasound.


Secondary Outcome Measures:
  • Body fat percentage [ Time Frame: 4 weeks, with optional additional 4 week treatment period ] [ Designated as safety issue: No ]
    Body fat percentage will be measured using a DEXA scan.

  • inflammation biomarkers [ Time Frame: 4 weeks, with optional additional 4 week treatment period ] [ Designated as safety issue: No ]
    Fasting blood draw

  • cognitive function [ Time Frame: 4 weeks, with optional additional 4 week treatment period ] [ Designated as safety issue: No ]
    cognitive function will be assessed using a validated computer based assessment tool


Enrollment: 44
Study Start Date: November 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill
Subject will take placebo for daily 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.
Active Comparator: Dietary Supplement: resveratrol
Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.
 Dietary Supplement: resveratrol
Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.

Detailed Description:

Measurements

  • blood laboratory parameters
  • cognitive assessment changes
  • body composition changes
  • vascular endothelial response
  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244360

Locations
United States, Pennsylvania
Marywood University
Scranton, Pennsylvania, United States, 18509
Sponsors and Collaborators
Marywood University
Investigators
Principal Investigator: James Smoliga, Ph.D. Marywood University
  More Information

No publications provided

Responsible Party: JAmes Smoliga, Ph.D., Marywood University
ClinicalTrials.gov Identifier: NCT01244360     History of Changes
Other Study ID Numbers: MU Smoliga Resveratrol, 2RESMU194218
Study First Received: November 17, 2010
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Marywood University:
resveratrol
insulin
inflammation
cognition
metabolism

Additional relevant MeSH terms:
Resveratrol
Inflammation
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
 Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 21, 2013