Physical Function Clinical Trial
— REVIVEOfficial title:
Phase IIa Study of Resveratrol to Enhance Mitochondrial and Physical Function in Older Adults
Verified date | April 2024 |
Source | University of Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Resveratrol, a compound found in red wine and dark-skinned grapes, will improve the function of mitochondria (energy producing components) within the leg muscles of moderate functioning older adults. The investigators will look at the role Resveratrol plays in improving physical function by studying the connection of changes in mitochondrial function and changes in physical function.
Status | Completed |
Enrollment | 60 |
Est. completion date | May 2, 2019 |
Est. primary completion date | May 2, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years and older |
Eligibility | Inclusion Criteria: - Ability to understand study procedures and to comply with them for the entire length of the study; - Age 65 years and older; - Moderate to high functioning (i.e. a summary score of 4 - 10 on the Short Physical Performance Battery [SPPB]); - Body Mass Index (BMI) range: 20-39.9 kg/m2; - Willingness to undergo all testing procedures. Exclusion Criteria: - Failure to provide informed consent; - Allergy/sensitivity to grapes or Japanese knotweed; - Current dietary supplementation of grape seed extract or ginko biloba; - Consumption of = 8 oz. of red wine/dealcoholized red wine/red or purple grape juice more than once weekly; - Consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum in the previous 90 days; - Active treatment for cancer, stroke (< 6 months), peripheral vascular disease, coronary artery disease, myocardial infarction (< 6 months), congestive heart failure (stage III or IV), valvular heart disease, major psychiatric disease, severe anemia (blood levels of Hemoglobin < 8 g/dl), liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity ( < 6 months), upper or lower extremity amputation, or Parkinson's disease; - Cognitive impairment (i.e. Mini Mental Status Exam = 23); - History of significant head injury; - Physical activity (i.e. running, bicycling, etc.) = 120 min/week; - Excessive alcohol use (> 2 drinks/day) or alcohol abuse (> 5 drinks/day for males, or > 4 drinks/day for females); - History of substance abuse within the past six months; - Mood disorder (i.e. Center for Epidemiological Studies - Depression (CES-D) = 16); - History of tobacco use within the past three years; - Resting heart rate > 120 bpm at screening visit; - Systolic blood pressure > 160 mm Hg at screening visit; - Diastolic blood pressure > 90 mm Hg at screening visit; - Fasting glucose = 126 mg/dL at screening visit; - Abnormalities in blood chemistry parameters, defined by blood chemistry marker outside of healthy range); - Current use of anabolic treatments (e.g. growth hormone or testosterone), anticholinesterase inhibitor (e.g. Aricept), hormone replacement (e.g. Estrogen), or anticoagulant therapies (note: aspirin use (= 81mg/day) is permitted); - Participation in another clinical trial, or has received an investigational product within 30 days prior to screening/enrollment; - Refuse to refrain from CoQ10 or alpha-lipoic acid while enrolled in the study. Temporary Exclusion Criteria - Recent bacterial/viral infection (< 2 weeks); - Acute febrile illness in past 2 months; - High blood pressure (i.e. = 140/90 mm Hg but = 160/90) at the screening visit; - Major surgery or hip/knee replacement (< 6 months). |
Country | Name | City | State |
---|---|---|---|
United States | UF Institute on Aging Clinical and Translational Research Building | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Florida | National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Mitochondrial Respiration in Muscle | Change in mitochondrial respiration (State 3) in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). | Baseline to 90 Days | |
Primary | Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples | Change in cytochrome oxidase (COX) in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days). | Baseline to 90 days | |
Primary | Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples | Change in citrate synthase (CS) enzymes in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days). | Baseline to 90 Days | |
Primary | Change From Baseline in Mitochondrial DNA Content in Muscle Samples | Change in mitochondrial DNA content in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days). | Baseline and 90 Days | |
Secondary | Change From Baseline in PGC-1a Muscle Protein Levels | Change in muscle protein levels, such as PGC-1a (primary outcome) in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). Arbitrary units are used for measurement as it is common for protein expression data since we do not measure absolute content of a specific protein within a sample. | Baseline to 90 Days | |
Secondary | Change From Baseline in Walking Speed. | Change in physical function, such as walking speed from baseline to post-test (90 days). The Six Minute Walk Test was used to measure data and involved participants being asked to walk as far and as fast as possible for 6-minutes on a 40m track. | Baseline to 90 Days | |
Secondary | Blood Glucose Level | Change in levels of blood glucose (metabolic risk factor) from baseline to post-test (90 days). | Baseline to 90 Days | |
Secondary | Physical Activity Levels | Change in levels of spontaneous physical activity from baseline to post-test (90 days). Measured using an accelerometer which is a wearable device that captures acceleration (counts) in real time, in multiple planes. Can be used to measure energy expenditure or stationary activity levels. | Baseline to 90 Days | |
Secondary | Change From Baseline in AMPK Muscle Protein Levels. | Change in muscle protein levels, such as AMPK in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). Arbitrary units are used for measurement as it is common for protein expression data since we do not measure absolute content of a specific protein within a sample. | Baseline to 90 Days | |
Secondary | Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels. | Change in muscle protein levels, such as sirtuins (SIRT1), in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). Arbitrary units are used for measurement as it is common for protein expression data since we do not measure absolute content of a specific protein within a sample. | Baseline to 90 Days | |
Secondary | Change From Baseline in Physical Performance | Change in Short Physical Performance Battery (SPPB) Test Total Score on a scale of 0-12 from baseline to post-test (90 days). Lower scores indicate more mobility limitations while higher scores indicate minimal to no mobility limitations. | Baseline to 90 Days | |
Secondary | Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels. | Change in muscle protein levels, such as sirtuins (SIRT3), in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). Arbitrary units are used for measurement as it is common for protein expression data since we do not measure absolute content of a specific protein within a sample. | Baseline to 90 days |
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