Aging
Conditions
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.
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.
Interventions
DRUGResveratrol
Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages
DRUGPlacebo
Vegetable-based cellulose
BEHAVIORALExercise
Multi-modal exercise regimen, 3 days/week
Sponsors
National Institute on Aging (NIA)
University of Alabama at Birmingham
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Physical Performance Battery (SPPB). | Change between baseline to 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. 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. |
| Isokinetic Strength. | Change between baseline and 12 weeks | 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. |
| 6-minute Walk Test | Change between Baseline and 12 weeks | 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. |
| Late-Life Function and Disability Instrument | Change at Baseline to 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo capsules will be taken orally following each meal three times daily
Placebo: Vegetable-based cellulose | 20 |
| Resveratrol 500 mg/Day 500 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages | 20 |
| Resveratrol 1000 mg/Day 1000 mg/day resveratrol taken orally following each meal three times daily
Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 1000 mg/day and 1500 mg/day dosages | 20 |
| Total | 60 |
Baseline characteristics
| Characteristic | Resveratrol 500 mg/Day | Placebo | Total | Resveratrol 1000 mg/Day |
|---|---|---|---|---|
| Age, Continuous | 73.4 years STANDARD_DEVIATION 5.63 | 75.72 years STANDARD_DEVIATION 5.94 | 74.1 years STANDARD_DEVIATION 5.78 | 73.8 years STANDARD_DEVIATION 5.73 |
| Body Mass Index | 31.3 kg/m^2 STANDARD_DEVIATION 7.6 | 31.1 kg/m^2 STANDARD_DEVIATION 5.5 | 31.5 kg/m^2 STANDARD_DEVIATION 6.7 | 32 kg/m^2 STANDARD_DEVIATION 6.9 |
| Diastolic Blood Pressure | 82.4 mmHg STANDARD_DEVIATION 9.5 | 79.3 mmHg STANDARD_DEVIATION 11.8 | 80.0 mmHg STANDARD_DEVIATION 9.8 | 78.2 mmHg STANDARD_DEVIATION 8.2 |
| Late-Life Function and Disability Instrument | 73.8 Scores on a scale STANDARD_DEVIATION 1.7 | 73.6 Scores on a scale STANDARD_DEVIATION 1.7 | 73.7 Scores on a scale STANDARD_DEVIATION 1.7 | 73.6 Scores on a scale STANDARD_DEVIATION 1.8 |
| Peak Knee Torque | 73 Newtons-Meter STANDARD_DEVIATION 2.6 | 73.3 Newtons-Meter STANDARD_DEVIATION 2.7 | 72.7 Newtons-Meter STANDARD_DEVIATION 2.7 | 71.7 Newtons-Meter STANDARD_DEVIATION 2.8 |
| Race/Ethnicity, Customized Hispanic | 1 Participants | 1 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 6 Participants | 4 Participants | 13 Participants | 3 Participants |
| Race/Ethnicity, Customized Non-Hispanic other | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 13 Participants | 14 Participants | 43 Participants | 16 Participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 45 Participants | 18 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 15 Participants | 2 Participants |
| Six-minute walk test | 1.0 m/s STANDARD_DEVIATION 0.02 | 1.0 m/s STANDARD_DEVIATION 0.02 | 1.0 m/s STANDARD_DEVIATION 0.02 | 1.0 m/s STANDARD_DEVIATION 0.02 |
| SPPB Total Score | 10.4 units on a scale STANDARD_DEVIATION 0.2 | 10.3 units on a scale STANDARD_DEVIATION 0.2 | 10.3 units on a scale STANDARD_DEVIATION 0.2 | 10.3 units on a scale STANDARD_DEVIATION 0.2 |
| Systolic Blood Pressure | 145 mmHg STANDARD_DEVIATION 15.1 | 140 mmHg STANDARD_DEVIATION 13.7 | 139.3 mmHg STANDARD_DEVIATION 12.8 | 133 mmHg STANDARD_DEVIATION 9.6 |
| Waist Circumference | 105 cm STANDARD_DEVIATION 20.3 | 98.4 cm STANDARD_DEVIATION 26.1 | 102.1 cm STANDARD_DEVIATION 21.2 | 103 cm STANDARD_DEVIATION 17.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 8 / 20 | 3 / 20 | 8 / 20 |
| serious Total, serious adverse events | 1 / 20 | 0 / 20 | 0 / 20 |
Outcome results
Primary
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.
Time frame: Change at Baseline to 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Walking Speed | -0.04 m/s |
| Resveratrol 500 mg/Day | Walking Speed | -0.03 m/s |
| Resveratrol 1000 mg/Day | Walking Speed | 0.04 m/s |
Secondary
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.
Time frame: Change between Baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | 6-minute Walk Test | 9.34 Meters |
| Resveratrol 500 mg/Day | 6-minute Walk Test | 22.9 Meters |
| Resveratrol 1000 mg/Day | 6-minute Walk Test | 33.1 Meters |
Secondary
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.
Time frame: Change between baseline and 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Isokinetic Strength. | -3.24 Newtons-Meters |
| Resveratrol 500 mg/Day | Isokinetic Strength. | 10.5 Newtons-Meters |
| Resveratrol 1000 mg/Day | Isokinetic Strength. | 6.15 Newtons-Meters |
Secondary
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.
Time frame: Change at Baseline to 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Late-Life Function and Disability Instrument | 4.77 Score on a scale |
| Resveratrol 500 mg/Day | Late-Life Function and Disability Instrument | 5.72 Score on a scale |
| Resveratrol 1000 mg/Day | Late-Life Function and Disability Instrument | 3.36 Score on a scale |
Secondary
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.
Time frame: Change between baseline to 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Placebo | Short Physical Performance Battery (SPPB). | 0.38 score on a scale |
| Resveratrol 500 mg/Day | Short Physical Performance Battery (SPPB). | 0.25 score on a scale |
| Resveratrol 1000 mg/Day | Short Physical Performance Battery (SPPB). | 0.13 score on a scale |