AgingPhase 2NCT02523274
Resveratrol and Exercise to Treat Functional Limitations in Late Life
A Phase 2 study testing Resveratrol and Exercise in people with Aging, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Aging
- What is being tested?
- Resveratrol and Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 17 Jul 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Center for Exercise Medicine
Birmingham, Alabama, 35294
About this study
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Resveratrol, Placebo, Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResveratrolDrug
Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages
PlaceboDrug
Vegetable-based cellulose
ExerciseBehavioural
Multi-modal exercise regimen, 3 days/week
| Study group | Role | What they receive |
|---|---|---|
| Placebo + exercise | Placebo comparator | Placebo capsules will be taken orally daily in combination with exercise Receives: Drug: Placebo; Behavioral: Exercise |
| Resveratrol 500 mg/day + exercise | Experimental | 500 mg/day resveratrol taken orally in combination with exercise Receives: Drug: Resveratrol; Behavioral: Exercise |
| Resveratrol 1000 mg/day + exercise | Experimental | 1000 mg/day resveratrol taken orally in combination with exercise Receives: Drug: Resveratrol; Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change at Baseline to 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change at Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJun 2016
- Primary completionMay 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Thomas Buford, PhD, Principal investigator, University of Alabama at BirminghamStephen Anton, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523274
- Sponsor's protocol ID
- IRB201500598 -N
- Other IDs
- R21AG049974
- Status last verified
- Dec 2021
- First submitted
- 10 Aug 2015
- Last updated
- 13 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resveratrol and Exercise to Treat Functional Limitations in Late Life
- ClinicalTrials.gov ID
- NCT02523274
- Acronym / sponsor ID
- IRB201500598 -N
- Conditions
- Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Alabama at Birmingham
- Study start
- Jun 2016
- Primary completion
- May 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 14 Aug 2015 (estimated)
- Results
- Posted 13 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo + exercise | Placebo comparator | Drug: Placebo, Behavioral: ExercisePlacebo capsules will be taken orally daily in combination with exercise |
| Resveratrol 500 mg/day + exercise | Experimental | Drug: Resveratrol, Behavioral: Exercise500 mg/day resveratrol taken orally in combination with exercise |
| Resveratrol 1000 mg/day + exercise | Experimental | Drug: Resveratrol, Behavioral: Exercise1000 mg/day resveratrol taken orally in combination with exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResveratrolDietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages | Drug | Resveratrol 1000 mg/day + exercise, Resveratrol 500 mg/day + exercise |
| PlaceboVegetable-based cellulose | Drug | Placebo + exercise |
| ExerciseMulti-modal exercise regimen, 3 days/week | Behavioural | Placebo + exercise, Resveratrol 1000 mg/day + exercise, Resveratrol 500 mg/day + exercise |
Primary outcome
Walking Speed
Time frame: Change at Baseline to 12 weeks
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.
4 secondary outcomes
Short Physical Performance Battery (SPPB).
Time frame: Change between baseline to 12 weeks
Isokinetic Strength.
Time frame: Change between baseline and 12 weeks
6-minute Walk Test
Time frame: Change between Baseline and 12 weeks
Late-Life Function and Disability Instrument
Time frame: Change at Baseline to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Buford, PhD principal investigator
University of Alabama at Birmingham
Stephen Anton principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol and Exercise in people with Aging, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Speed (time frame: Change at Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.