Resveratrol and Exercise to Treat Functional Limitations in Late Life

NCT ID: NCT02523274

Last Updated: 2022-01-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-07-17

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo + exercise

Placebo capsules will be taken orally daily in combination with exercise

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vegetable-based cellulose

Exercise

Intervention Type BEHAVIORAL

Multi-modal exercise regimen, 3 days/week

Resveratrol 500 mg/day + exercise

500 mg/day resveratrol taken orally in combination with exercise

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages

Exercise

Intervention Type BEHAVIORAL

Multi-modal exercise regimen, 3 days/week

Resveratrol 1000 mg/day + exercise

1000 mg/day resveratrol taken orally in combination with exercise

Group Type EXPERIMENTAL

Resveratrol

Intervention Type DRUG

Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages

Exercise

Intervention Type BEHAVIORAL

Multi-modal exercise regimen, 3 days/week

Interventions

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Resveratrol

Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages

Intervention Type DRUG

Placebo

Vegetable-based cellulose

Intervention Type DRUG

Exercise

Multi-modal exercise regimen, 3 days/week

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Buford, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Stephen Anton

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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UAB Center for Exercise Medicine

Birmingham, Alabama, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R21AG049974

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB201500598 -N

Identifier Type: -

Identifier Source: org_study_id

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