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Resveratrol and Exercise to Treat Functional Limitations in Late Life

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ClinicalTrials.gov Identifier: NCT02523274
Recruitment Status : Active, not recruiting
First Posted : August 14, 2015
Last Update Posted : August 13, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
University of Alabama at Birmingham
Information provided by (Responsible Party):
University of Florida

Brief Summary:
The purpose of this research study is to evaluate the effects of combining physical exercise with a resveratrol supplementation on the physical function of older adults.

Condition or disease Intervention/treatment Phase
Aging Drug: Resveratrol Drug: Placebo Behavioral: Exercise Phase 2

Detailed Description:
This investigation is a pilot study to investigate the potential of resveratrol, a commercially-available nutritional product, to enhance the efficacy of physical exercise in improving physical function among older adults with functional limitations. The overarching objective of this project is to evaluate the safety and efficacy of an intervention combining resveratrol supplementation and physical exercise among sedentary persons aged > 65 years objectively-measured functional impairments. A total of 60 participants will be recruited to participate in this three month intervention study. All participants will engage in a center-based exercise program 3/days per week and will be randomly assigned to consume 1) placebo, 2) 250 mg/day resveratrol, or 3) 1000 mg/day resveratrol. This study will provide critical information regarding the influence of the combination of resveratrol and exercise on objectively-measured and self-assessed indices of physical function. The study will also provide novel biologic information regarding the relative effects of the interventions on skeletal muscle mitochondrial function.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Resveratrol and Exercise to Treat Functional Limitations in Late Life
Study Start Date : June 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Resveratrol

Arm Intervention/treatment
Placebo Comparator: Placebo + exercise
Placebo capsules will be taken orally daily in combination with exercise
Drug: Placebo
Vegetable-based cellulose

Behavioral: Exercise
Multi-modal exercise regimen, 3 days/week

Experimental: Resveratrol 250 mg/day + exercise
250 mg/day resveratrol taken orally in combination with exercise
Drug: Resveratrol
Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages

Behavioral: Exercise
Multi-modal exercise regimen, 3 days/week

Experimental: Resveratrol 1000 mg/day + exercise
1000 mg/day resveratrol taken orally in combination with exercise
Drug: Resveratrol
Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages

Behavioral: Exercise
Multi-modal exercise regimen, 3 days/week




Primary Outcome Measures :
  1. Walking Speed changes between the groups at baseline, 6, and 12 weeks. [ Time Frame: Change at Baseline, 6, and 12 weeks ]
    Walking speed is assess speed by asking the participants to walk at their usual pace over a 4 m course. Participants are to stand with both feet touching the starting line and to start walking after a verbal command is given, and the time needed to complete the entire distance will be recorded. The faster of two walks will be used.


Secondary Outcome Measures :
  1. Short Physical Performance Battery (SPPB) changes between the groups at baseline, 6, and 12 weeks. [ Time Frame: Change at Baseline, 6, and 12 weeks ]
    Investigators will assess lower-extremity function by asking the participants to perform a series of tasks including: walking at their usual pace over a 4 m course, repeated chair stands, and a balance test. Each task is scored from 0 to 4, with 4 indicating best level of performance and 0 the inability to complete the test. A summary score (0-12) is then calculated.

  2. Skeletal Muscle Function assessed by a dynamometer will demonstrate changes between the groups at baseline, 6, and 12 weeks. [ Time Frame: Change at Baseline, 6, and 12 weeks ]
    Isokinetic strength and endurance of the knee flexors and extensors of the dominant limb will be assessed by a standard dynamometer.

  3. 6-minute walk test changes between the groups at baseline, 6, and 12 weeks. [ Time Frame: Change at Baseline, 6, and 12 weeks ]
    Investigators will assess exercise capacity of participants using the six-minute (6-min) walk test,

  4. Late-Life Function and Disability Instrument changes between the groups at baseline, 6, and 12 weeks. [ Time Frame: Change at Baseline, 6, and 12 weeks ]
    The instrument includes 16 tasks representing a broad range of disability indicators that assesses both frequency of doing a task and perceived limitation. The instrument uses a scale from 0 to 100, with higher scores indicating higher levels of function.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to understand study procedures and to comply with them for the entire length of the study
  • Willingness to be randomized into either treatment group
  • Age 65 years and older
  • Physical limitations evidenced by >290 seconds needed to complete long-distance corridor walk test
  • Sedentary lifestyle, defined as <150 min/wk of moderate physical activity as assessed by CHAMPS questionnaire

Exclusion Criteria:

  • Failure to provide informed consent
  • Regular consumption of a resveratrol supplement
  • Current involvement in supervised rehabilitation program
  • Absolute contraindication(s) to exercise training according to American College of Sports Medicine guidelines
  • Pain classification > Grade 3 on Graded Chronic Pain Scale
  • Peripheral vascular disease; peripheral neuropathy; retinopathy
  • Severe cardiac disease, including:

NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina

  • Myocardial infarction or stroke within past year
  • Significant cognitive impairment, including:

known dementia diagnosis or a Mini-Mental State Examination exam score <24

  • Progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
  • Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease)
  • Severe pulmonary disease, requiring either steroid pills or injections or the use of supplemental oxygen
  • Hip fracture, hip or knee replacement, or spinal surgery within past 4 mos.
  • Other significant co-morbid conditions that would impair ability to participate in the exercise-based intervention
  • Simultaneous participation in another intervention trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523274


Locations
United States, Alabama
UAB Center for Exercise Medicine
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Florida
National Institute on Aging (NIA)
University of Alabama at Birmingham
Investigators
Principal Investigator: Thomas Buford, PhD University of Alabama at Birmingham
Principal Investigator: Stephen Anton University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02523274     History of Changes
Other Study ID Numbers: IRB201500598 -N
R21AG049974 ( U.S. NIH Grant/Contract )
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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