Resveratrol and Exercise to Treat Functional Limitations in Late Life

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Drug: Placebo; Behavioral: Exercise; Drug: Resveratrol

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) 500 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
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Center for Exercise Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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 500 mg/day + exercise; 500 mg/day resveratrol taken orally in combination with exercise	Behavioral: Exercise; Multi-modal exercise regimen, 3 days/week; Drug: Resveratrol; Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages
Experimental: Resveratrol 1000 mg/day + exercise; 1000 mg/day resveratrol taken orally in combination with exercise	Behavioral: Exercise; Multi-modal exercise regimen, 3 days/week; Drug: Resveratrol; Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Walking Speed	Walking speed is assessed 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 and changes between the groups at baseline and 12 weeks will be assessed.	Change at Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Physical Performance Battery (SPPB).	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. Higher score on the scale is reflective of higher function and lower score reflects lower functioning. Changes between the groups at baseline and 12 weeks will be assessed.	Change between baseline to 12 weeks
Isokinetic Strength.	Isokinetic strength of the dominant limb will be assessed by a standard dynamometer and changes between the groups at baseline and 12 weeks will be assessed.	Change between baseline and 12 weeks
6-minute Walk Test	Investigators will assess exercise capacity of participants using the six-minute (6-min) walk test to assess change in meters walked between the groups at baseline and 12 weeks.	Change between Baseline and 12 weeks
Late-Life Function and Disability Instrument	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.	Change at Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: University of Alabama at Birmingham; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Stephen Anton, University of Florida

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): July 17, 2019

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 11, 2015
• First Posted (Estimate): August 14, 2015

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; Resveratrol
• Other Study ID Numbers: IRB201500598 -N; R21AG049974 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No