Mitochondrial Function, Physical Function
Conditions
Keywords
Aging, Biogenesis, Cell Respiration, Elderly, Enzymes, Mitochondria, Mitochondrial DNA, Muscle Fatigue, Physical Function, Resveratrol
Brief summary
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.
Detailed description
An initial telephone screening indicated that the subject may be eligible to participate in the study. The first study visit (Screening visit) will further determine if the subject is eligible to participate. Should the subject be eligible to participate in the study, the subject will be asked to participate in a daily resveratrol or placebo supplementation program for approximately 90 days. The subject will also be asked to return to the clinic for two additional assessment visits to monitor his/her safety and measure study results. Details regarding the tests to be conducted during this screening visit and other study visits are described below. Visits will take place at the University of Florida Institute on Aging (IOA). The Screening Visit is approximately 1.5 to 2 hours and will include: 1. Blood Draw: The subject is asked to fast before the appointment because blood will be collected during this visit. The investigator will collect approximately 2 tablespoons of blood. The purpose of this blood draw is to determine levels of certain compounds in the subject's blood that will help determine eligibility. 2. Questionnaires: The subject will be asked questions about medical history and medications as well as mood and will also be asked to complete a short test of memory and reasoning. 3. Physical Measurements: measurements of the subject's height, body weight, waist circumference, pulse, and blood pressure. 4. Physical Exam: A licensed health care provider will perform a brief physical exam to determine if it is safe to continue with the study. This exam will include a review of medical history, medications, and measurement of height, blood pressure, radial pulse, weight, and waist circumference. 5. Tests of physical performance: The subject will be asked to complete tests of physical ability that include: 1. Walking at the usual pace for a distance of 13 feet (4 meters) two (2) separate times 2. The subject will be asked to go from a standing to a sitting position, without using their arms. If the subject is able to perform this task, then they will be asked to stand up from and sit down on chair five (5) times as fast as possible. 3. Maintaining balance while standing in three (3) different positions Baseline Visit 1: Should the subject be eligible for the study, they will be asked to return to the clinic for the first baseline study visit. This visit is expected to take 2 to 3 hours and will include: 1. Measurement of pulse and blood pressure 2. Measurement of body weight and waist circumference 3. Collection of fasting blood samples 4. Questions about the subject's health 5. Tests of physical performance, including: 1. Walking as fast and far as the subject can for 6 minutes 2. Walking at subject's usual pace for a distance of 13 feet (4 meters) two (2) separate times 3. Standing from a sitting position, without using their arms. If the subject is able to perform this task, then they will be asked to stand up from and sit down on chair five (5) times as fast as possible. 4. Maintaining balance while standing in three (3) different positions. 5. Assessment of lower-body muscle strength and endurance 6. Physical Activity Monitor: The subject will also be asked to wear an armband physical activity monitor during a typical seven day period to assess baseline physical activity habits. The monitor will be returned at Baseline Visit 2. Baseline Visit 2 will take approximately 2 hours and will include: 1. Measurement of pulse and blood pressure before procedure 2. Muscle Tissue Sample: The procedure to collect muscle samples will be performed by a licensed healthcare provider with experience conducting the procedure. The procedure includes numbing a small area on the thigh with a local anesthetic and then using a needle about the size of a pen to collect a small amount of muscle tissue approximately equal to the size of the head of a pencil eraser. After the tissue sample is taken, the subject will receive detailed instruction on how to care for the incision site. Several follow-up phone assessments will be made inquiring about any problems that the subject may be experiencing related to the procedure. 3. Measurement of pulse and blood pressure after procedure 4. Randomization: Subjects who are eligible and safe to continue with the study, will be randomly assigned to one of three conditions: (1) resveratrol (1000 mg/day) (2) resveratrol (1500 mg/day) or (3) placebo (vegetable cellulose). 5. The subject will be provided with a supply of the study drug capsules of at least 30 days and will be asked to return any remaining study drug capsules to the clinic at the next appointment. Subjects will be asked to orally consume one study drug capsule following each main meal (i.e. breakfast, lunch and dinner) with a glass of water. 30-Day & 60-Day Visits last approximately 1 hour and include: 1. Collection of fasting blood samples 2. Measurement of pulse and blood pressure 3. Measurement of weight and waist circumference 4. Update medical history and ask questions about any adverse experiences the subject may have had since the last visit 5. Counting of any remaining study drug capsules that were not taken since last visit 6. Providing the subject with study drug capsules needed until the next study visit 90-Day Visit 1 is similar to the Baseline 1 visit and will last approximately 2-3 hours. This visit includes: 1. Measurement of pulse and blood pressure 2. Measurement of body weight and waist circumference 3. Collection of fasting blood samples 4. Update medical history and ask questions about any adverse experiences the subject may have had since last visit 5. Counting of any remaining study drug capsules that were not taken since last visit 6. Tests of physical performance, including: 1. Walking as fast and far as possible for 6 minutes 2. Walking at usual pace for a distance of 13 feet (4 meters) two (2) separate times 3. Standing from a sitting position, without using arms. If the subject is able to perform this task, he/she will be to stand up from and sit down on chair five (5) times as fast as possible. 4. Maintaining balance while standing in three (3) different positions. 5. Assessment of lower-body muscle strength and endurance 7. The subject will receive an armband physical activity monitor to wear for seven days, and will be asked to return this monitor at the 90-Day Visit 2. 90-Day Visit 2 will be similar to the Baseline 2 visit and will last approximately 1.5 to 2 hours. 1. Procedure to collect muscle tissue sample (as described in Baseline 2) 2. Counting of any remaining study drug capsules that were not taken since last visit. Follow-Up 10-Day & 30-Day Visits are approximately 30 minutes to 1 hour 1. Measurement of pulse and blood pressure 2. Collection of fasting blood samples 3. Update medical history and ask questions about any adverse experiences the subject may have had since last visit
Interventions
DRUGResveratrol 1000 mg/day
Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
DRUGResveratrol 1500 mg/day
Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
OTHERVegetable cellulose
Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
OTHERAll groups
All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mitochondrial Respiration in Muscle | Baseline to 90 Days | Change in mitochondrial respiration (State 3) in muscle samples of moderate-to-low functioning older adults from baseline to post-test (90 days). |
| Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples | Baseline to 90 days | Change in cytochrome oxidase (COX) in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days). |
| Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples | Baseline to 90 Days | Change in citrate synthase (CS) enzymes in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days). |
| Change From Baseline in Mitochondrial DNA Content in Muscle Samples | Baseline and 90 Days | Change in mitochondrial DNA content in muscle samples of moderate-to-low functioning in older adults from baseline to post-test (90 days). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in AMPK Muscle Protein Levels. | Baseline to 90 Days | 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. |
| Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels. | Baseline to 90 Days | 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. |
| Change From Baseline in PGC-1α Muscle Protein Levels | Baseline to 90 Days | Change in muscle protein levels, such as PGC-1α (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. |
| Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels. | Baseline to 90 days | 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. |
| Change From Baseline in Physical Performance | Baseline to 90 Days | 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. |
| Change From Baseline in Walking Speed. | Baseline to 90 Days | 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. |
| Blood Glucose Level | Baseline to 90 Days | Change in levels of blood glucose (metabolic risk factor) from baseline to post-test (90 days). |
| Physical Activity Levels | Baseline to 90 Days | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vegetable Cellulose Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days.
Vegetable cellulose: Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples. | 20 |
| Resveratrol 1000 mg/Day Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1000 mg/day for 90 days.
Resveratrol 1000 mg/day: Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples. | 21 |
| Resveratrol 1500 mg/Day Participants will orally consume one capsule of Resveratrol following each of their main meals (i.e. breakfast, lunch, and dinner) totaling 1500 mg/day for 90 days.
Resveratrol 1500 mg/day: Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
All groups: All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples. | 19 |
| Total | 60 |
Baseline characteristics
| Characteristic | Vegetable Cellulose | Resveratrol 1000 mg/Day | Resveratrol 1500 mg/Day | Total |
|---|---|---|---|---|
| Age, Continuous | 75.72 years STANDARD_DEVIATION 5.94 | 73.4 years STANDARD_DEVIATION 5.63 | 73.18 years STANDARD_DEVIATION 5.78 | 74.1 years STANDARD_DEVIATION 5.78 |
| Body Mass Index | 28.1 kg/m^2 STANDARD_DEVIATION 4.4 | 27.8 kg/m^2 STANDARD_DEVIATION 3.8 | 29.3 kg/m^2 STANDARD_DEVIATION 5.3 | 28.4 kg/m^2 STANDARD_DEVIATION 4.5 |
| Diastolic Blood Pressure | 74.7 mmHg STANDARD_DEVIATION 9.3 | 77.0 mmHg STANDARD_DEVIATION 8.6 | 75.4 mmHg STANDARD_DEVIATION 7.9 | 75.4 mmHg STANDARD_DEVIATION 8.6 |
| Glucose | 98.6 mg/dL STANDARD_DEVIATION 9.5 | 92.4 mg/dL STANDARD_DEVIATION 7.4 | 94.3 mg/dL STANDARD_DEVIATION 9.1 | 95.1 mg/dL STANDARD_DEVIATION 8.7 |
| Highest Level of Education College | 5 Participants | 9 Participants | 9 Participants | 23 Participants |
| Highest Level of Education High School/Equivalent | 5 Participants | 4 Participants | 5 Participants | 14 Participants |
| Highest Level of Education Other | 3 Participants | 0 Participants | 0 Participants | 3 Participants |
| Highest Level of Education Post-Graduate | 7 Participants | 8 Participants | 5 Participants | 20 Participants |
| Income <$35,000 | 9 Participants | 9 Participants | 7 Participants | 25 Participants |
| Income $35,000-$74,999 | 7 Participants | 8 Participants | 9 Participants | 24 Participants |
| Income >=$75,000 | 3 Participants | 2 Participants | 2 Participants | 7 Participants |
| Income Don't Know/Refused | 1 Participants | 2 Participants | 1 Participants | 4 Participants |
| Knee Flexion | 32.2 Peak Torque (nm) STANDARD_DEVIATION 14 | 37.4 Peak Torque (nm) STANDARD_DEVIATION 15.8 | 31.2 Peak Torque (nm) STANDARD_DEVIATION 12.4 | 33.6 Peak Torque (nm) STANDARD_DEVIATION 13.7 |
| Live Alone No | 14 Participants | 16 Participants | 12 Participants | 42 Participants |
| Live Alone Yes | 6 Participants | 5 Participants | 7 Participants | 18 Participants |
| Marital Status Married | 10 Participants | 11 Participants | 5 Participants | 26 Participants |
| Marital Status Never Married | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Marital Status Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Marital Status Separated/Divorced/Widowed | 8 Participants | 10 Participants | 13 Participants | 31 Participants |
| Mitochondrial DNA Content | 384.3 ratio STANDARD_DEVIATION 139.9 | 409.1 ratio STANDARD_DEVIATION 127.4 | 329.3 ratio STANDARD_DEVIATION 86.1 | 374.2 ratio STANDARD_DEVIATION 117.8 |
| PGC-1 alpha | 0.48 arbitrary units STANDARD_DEVIATION 0.12 | 0.52 arbitrary units STANDARD_DEVIATION 0.16 | 0.55 arbitrary units STANDARD_DEVIATION 0.19 | 0.52 arbitrary units STANDARD_DEVIATION 0.16 |
| Physical Activity | 44.0 minutes in moderate/vigorous activity STANDARD_DEVIATION 26.5 | 44.2 minutes in moderate/vigorous activity STANDARD_DEVIATION 22.5 | 49.2 minutes in moderate/vigorous activity STANDARD_DEVIATION 22.5 | 45.8 minutes in moderate/vigorous activity STANDARD_DEVIATION 23.8 |
| Race/Ethnicity, Customized Hispanic | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 1 Participants | 3 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Non-Hispanic Other | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 16 Participants | 18 Participants | 13 Participants | 47 Participants |
| Sex: Female, Male Female | 12 Participants | 12 Participants | 13 Participants | 37 Participants |
| Sex: Female, Male Male | 8 Participants | 9 Participants | 6 Participants | 23 Participants |
| Short Physical Performance Battery (SPPB) | 10.6 units on a scale (0-12) STANDARD_DEVIATION 2 | 11.0 units on a scale (0-12) STANDARD_DEVIATION 1.5 | 11.3 units on a scale (0-12) STANDARD_DEVIATION 0.7 | 11.0 units on a scale (0-12) STANDARD_DEVIATION 1.4 |
| SIRT-1 | 0.7 arbitrary units STANDARD_DEVIATION 0.25 | 0.79 arbitrary units STANDARD_DEVIATION 0.29 | 0.71 arbitrary units STANDARD_DEVIATION 0.18 | 0.73 arbitrary units STANDARD_DEVIATION 0.24 |
| SIRT-3 | 0.37 arbitrary units STANDARD_DEVIATION 0.14 | 0.42 arbitrary units STANDARD_DEVIATION 0.14 | 0.43 arbitrary units STANDARD_DEVIATION 0.18 | 0.41 arbitrary units STANDARD_DEVIATION 0.15 |
| Six Minute Walk | 1.2 meters per second STANDARD_DEVIATION 0.3 | 1.2 meters per second STANDARD_DEVIATION 0.2 | 1.1 meters per second STANDARD_DEVIATION 0.1 | 1.2 meters per second STANDARD_DEVIATION 0.2 |
| Waist Circumference | 98.4 Centimeters STANDARD_DEVIATION 9.3 | 99.2 Centimeters STANDARD_DEVIATION 10.8 | 100.1 Centimeters STANDARD_DEVIATION 18.4 | 99.2 Centimeters STANDARD_DEVIATION 12.8 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 14 / 20 | 12 / 21 | 16 / 19 |
| serious Total, serious adverse events | 0 / 20 | 0 / 21 | 0 / 19 |
Outcome results
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).
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples | -0.02 nmol/min/mg protein |
| Resveratrol 1000 mg/Day | Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples | 0.08 nmol/min/mg protein |
| Resveratrol 1500 mg/Day | Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples | -0.09 nmol/min/mg protein |
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).
Time frame: Baseline to 90 days
Population: Population measured after participant dropout.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vegetable Cellulose | Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples | 109.4 nmol/min/mg/protein | Standard Deviation 58.26 |
| Resveratrol 1000 mg/Day | Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples | 126.7 nmol/min/mg/protein | Standard Deviation 34.1 |
| Resveratrol 1500 mg/Day | Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples | 121.2 nmol/min/mg/protein | Standard Deviation 48.46 |
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).
Time frame: Baseline and 90 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Change From Baseline in Mitochondrial DNA Content in Muscle Samples | 2.71 Ratio |
| Resveratrol 1000 mg/Day | Change From Baseline in Mitochondrial DNA Content in Muscle Samples | 7.13 Ratio |
| Resveratrol 1500 mg/Day | Change From Baseline in Mitochondrial DNA Content in Muscle Samples | -7.31 Ratio |
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).
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Change From Baseline in Mitochondrial Respiration in Muscle | -3.05 nmol O2/s/mg wwt |
| Resveratrol 1000 mg/Day | Change From Baseline in Mitochondrial Respiration in Muscle | -4.82 nmol O2/s/mg wwt |
| Resveratrol 1500 mg/Day | Change From Baseline in Mitochondrial Respiration in Muscle | -4.56 nmol O2/s/mg wwt |
Secondary
Blood Glucose Level
Change in levels of blood glucose (metabolic risk factor) from baseline to post-test (90 days).
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Blood Glucose Level | 9.49 mg/dL |
| Resveratrol 1000 mg/Day | Blood Glucose Level | 0.74 mg/dL |
| Resveratrol 1500 mg/Day | Blood Glucose Level | 2.94 mg/dL |
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.
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vegetable Cellulose | Change From Baseline in AMPK Muscle Protein Levels. | 0.42 arbitrary units | Standard Deviation 0.37 |
| Resveratrol 1000 mg/Day | Change From Baseline in AMPK Muscle Protein Levels. | 0.72 arbitrary units | Standard Deviation 0.43 |
| Resveratrol 1500 mg/Day | Change From Baseline in AMPK Muscle Protein Levels. | 1.50 arbitrary units | Standard Deviation 2.44 |
Secondary
Change From Baseline in PGC-1α Muscle Protein Levels
Change in muscle protein levels, such as PGC-1α (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.
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Change From Baseline in PGC-1α Muscle Protein Levels | -0.10 arbitrary units |
| Resveratrol 1000 mg/Day | Change From Baseline in PGC-1α Muscle Protein Levels | -0.12 arbitrary units |
| Resveratrol 1500 mg/Day | Change From Baseline in PGC-1α Muscle Protein Levels | -0.07 arbitrary units |
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.
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Change From Baseline in Physical Performance | 0.18 units on a scale 0-12 |
| Resveratrol 1000 mg/Day | Change From Baseline in Physical Performance | -0.08 units on a scale 0-12 |
| Resveratrol 1500 mg/Day | Change From Baseline in Physical Performance | 0.06 units on a scale 0-12 |
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.
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels. | 0.03 arbitrary units |
| Resveratrol 1000 mg/Day | Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels. | 0.00 arbitrary units |
| Resveratrol 1500 mg/Day | Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels. | 0.01 arbitrary units |
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.
Time frame: Baseline to 90 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels. | 0.01 arbitrary units |
| Resveratrol 1000 mg/Day | Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels. | 0.01 arbitrary units |
| Resveratrol 1500 mg/Day | Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels. | -0.01 arbitrary units |
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.
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Vegetable Cellulose | Change From Baseline in Walking Speed. | 0.03 m/s |
| Resveratrol 1000 mg/Day | Change From Baseline in Walking Speed. | 0.06 m/s |
| Resveratrol 1500 mg/Day | Change From Baseline in Walking Speed. | 0.04 m/s |
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.
Time frame: Baseline to 90 Days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vegetable Cellulose | Physical Activity Levels | 167.0 Counts per minute | Standard Deviation 99.6 |
| Resveratrol 1000 mg/Day | Physical Activity Levels | 153.1 Counts per minute | Standard Deviation 69.2 |
| Resveratrol 1500 mg/Day | Physical Activity Levels | 170.9 Counts per minute | Standard Deviation 62.9 |