Resveratrol and Exercise to Treat Functional Limitations in Late Life

NCT02523274 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB201500598 -NR21AG049974
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Short Physical Performance Battery (SPPB).

  Change between baseline to 12 weeks

• Isokinetic Strength.

  Change between baseline and 12 weeks

• 6-minute Walk Test

  Change between Baseline and 12 weeks

• Late-Life Function and Disability Instrument

  Change at Baseline to 12 weeks

Study Arms (3)

Placebo + exercise

PLACEBO COMPARATOR

Placebo capsules will be taken orally daily in combination with exercise

Drug: Placebo; Behavioral: Exercise

Resveratrol 500 mg/day + exercise

EXPERIMENTAL

500 mg/day resveratrol taken orally in combination with exercise

Drug: Resveratrol; Behavioral: Exercise

Resveratrol 1000 mg/day + exercise

EXPERIMENTAL

1000 mg/day resveratrol taken orally in combination with exercise

Drug: Resveratrol; Behavioral: Exercise

Interventions

Resveratrol DRUG

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

Resveratrol 1000 mg/day + exercise; Resveratrol 500 mg/day + exercise

Placebo DRUG

Vegetable-based cellulose

Placebo + exercise

Exercise BEHAVIORAL

Multi-modal exercise regimen, 3 days/week

Placebo + exercise; Resveratrol 1000 mg/day + exercise; Resveratrol 500 mg/day + exercise

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Florida: lead
• National Institute on Aging (NIA): collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

UAB Center for Exercise Medicine

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Interventions

Resveratrol; Exercise

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Stephen Anton
• Organization: University of Florida

santon@ufl.edu

(352) 273-7514

Study Officials

• Thomas Buford, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Stephen Anton

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 14, 2015
• Study Start: June 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: July 17, 2019
• Last Updated: January 13, 2022
• Results First Posted: January 13, 2022

Record last verified: 2021-12

Locations

US (1)