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| ID | Type | Description | Link |
|---|---|---|---|
| R21AG049974 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| University of Alabama at Birmingham | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo + exercise | Placebo Comparator | Placebo capsules will be taken orally daily in combination with exercise |
|
| Resveratrol 500 mg/day + exercise | Experimental | 500 mg/day resveratrol taken orally in combination with exercise |
|
| Resveratrol 1000 mg/day + exercise | Experimental | 1000 mg/day resveratrol taken orally in combination with exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol | Drug | Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
NYHA Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, or uncontrolled angina
known dementia diagnosis or a Mini-Mental State Examination exam score <24
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Buford, PhD | University of Alabama at Birmingham | Principal Investigator |
| Stephen Anton | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Center for Exercise Medicine | Birmingham | Alabama | 35294 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo capsules will be taken orally following each meal three times daily Placebo: Vegetable-based cellulose |
| FG001 | Resveratrol 500 mg/Day | 500 mg/day resveratrol taken orally via capsule following each meal three times daily Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages |
| FG002 | Resveratrol 1000 mg/Day | 1000 mg/day resveratrol taken orally via capsule following each meal three times daily Resveratrol: Dietary compound commonly found in grapes and red wine. Will be given in 500 mg/day and 1000 mg/day dosages |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo capsules will be taken orally following each meal three times daily Placebo: Vegetable-based cellulose |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | m/s | Change at Baseline to 12 weeks |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo capsules will be taken orally following each meal three times daily Placebo: Vegetable-based cellulose |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heart Attack | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal Issues | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephen Anton | University of Florida | (352) 273-7514 | santon@ufl.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2015 | Nov 8, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 3, 2016 | Nov 8, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | Vegetable-based cellulose |
|
| Exercise | Behavioral | Multi-modal exercise regimen, 3 days/week |
|
| 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Waist Circumference | Mean | Standard Deviation | cm |
|
| Systolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| Six-minute walk test | Mean | Standard Deviation | m/s |
|
| SPPB Total Score | Score on scale of 0-12. Higher score (closer to 12) indicates better functioning. Lower score (closer to 0) indicates lower functioning. | Mean | Standard Deviation | units on a scale |
|
| Peak Knee Torque | Peak knee torque measured by knee extension. | Mean | Standard Deviation | Newtons-Meter |
|
| Late-Life Function and Disability Instrument | Method of assessing functional capacity and disability. Lower values correlate with lower functioning and higher values correlate with higher functioning. | Mean | Standard Deviation | Scores on a scale |
|
| OG002 | 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 |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Change between baseline to 12 weeks |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Newtons-Meters | Change between baseline and 12 weeks |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Meters | Change between Baseline and 12 weeks |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | Score on a scale | Change at Baseline to 12 weeks |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| 8 |
| 20 |
| EG001 | Resveratrol 500 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 | 0 | 20 | 0 | 20 | 3 | 20 |
| EG002 | Resveratrol 1000 mg/Day | 1500 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 | 0 | 20 | 0 | 20 | 8 | 20 |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Chest Pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Blood Sugar | Renal and urinary disorders | Systematic Assessment |
|
| Bladder Infection | Hepatobiliary disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Elevated Blood Pressure | Vascular disorders | Systematic Assessment |
|
| Heart Attack | Cardiac disorders | Systematic Assessment |
|
| Light headedness | General disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |