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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AT007564-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Office of Dietary Supplements (ODS) | NIH |
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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.
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:
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.
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.
Physical Measurements: measurements of the subject's height, body weight, waist circumference, pulse, and blood pressure.
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.
Tests of physical performance: The subject will be asked to complete tests of physical ability that include:
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:
Measurement of pulse and blood pressure
Measurement of body weight and waist circumference
Collection of fasting blood samples
Questions about the subject's health
Tests of physical performance, including:
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:
Measurement of pulse and blood pressure before procedure
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.
Measurement of pulse and blood pressure after procedure
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).
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:
90-Day Visit 1 is similar to the Baseline 1 visit and will last approximately 2-3 hours. This visit includes:
Measurement of pulse and blood pressure
Measurement of body weight and waist circumference
Collection of fasting blood samples
Update medical history and ask questions about any adverse experiences the subject may have had since last visit
Counting of any remaining study drug capsules that were not taken since last visit
Tests of physical performance, including:
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.
Follow-Up 10-Day & 30-Day Visits are approximately 30 minutes to 1 hour
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vegetable cellulose | Placebo Comparator | Participants will orally consume one capsule of vegetable cellulose following each of their main meals (i.e. breakfast, lunch, and dinner) for 90 days. |
|
| Resveratrol 1000 mg/day | Active Comparator | 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 1500 mg/day | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resveratrol 1000 mg/day | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to 90 Days |
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Inclusion Criteria:
Exclusion Criteria:
Temporary Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Stephen D. Anton, Ph.D. | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UF Institute on Aging Clinical and Translational Research Building | Gainesville | Florida | 32611 | United States |
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| Label | URL |
|---|---|
| University of Florida Institute on Aging | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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). | Posted | Mean | 95% Confidence Interval | nmol O2/s/mg wwt | Baseline to 90 Days |
|
90 days
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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 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea, Burning in Stomach, Loose Stool, Nausea and Vomiting, Constipation, | 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 | Jun 2, 2016 | Jan 8, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 4, 2018 | Apr 3, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000077185 | Resveratrol |
| ID | Term |
|---|---|
| D000081225 | Stilbestrols |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
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| Resveratrol 1500 mg/day | Drug | 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. |
|
| Vegetable cellulose | Other | 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 | Other | All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples. |
|
| 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 |
| Blood Glucose Level | Change in levels of blood glucose (metabolic risk factor) from baseline to post-test (90 days). | Baseline to 90 Days |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Marital Status | Count of Participants | Participants |
|
| Live Alone | Count of Participants | Participants |
|
| Highest Level of Education | Count of Participants | Participants |
|
| Income | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Physical Activity | Dropout occurred. | Mean | Standard Deviation | minutes in moderate/vigorous activity |
|
| Six Minute Walk | Test, where participants will be asked to walk as far and fast as possible for 6-min on a 40 m track | Mean | Standard Deviation | meters per second |
|
| Short Physical Performance Battery (SPPB) | The SPPB is designed to assess lower-extremity function by measuring three timed subtests: five timed repetitive chair stands, standing balance (i.e. hold tandem and semi-tandem foot position for 10 seconds), and gait speed during a 4 m walk at one's usual pace. Each subtest is scored from 0 to 4, with 0 indicating inability to complete test, and 4 indicating maximal performance. A summary score from 0 to 12 is calculated for the SPPB, where higher scores indicate better physical function. | Mean | Standard Deviation | units on a scale (0-12) |
|
| Knee Flexion | This test involves using an isokinetic dynamometer set at 90 degrees per second. Participants will perform 50 maximal knee extension and flexion concentric repetitions, which will be administered by trained and certified research assistants. | Mean | Standard Deviation | Peak Torque (nm) |
|
| Waist Circumference | Mean | Standard Deviation | Centimeters |
|
| Glucose | Mean | Standard Deviation | mg/dL |
|
| Diastolic Blood Pressure | Mean | Standard Deviation | mmHg |
|
| PGC-1 alpha | Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α) is a protein that in humans is encoded by the PPARGC1A gene. | Mean | Standard Deviation | arbitrary units |
|
| SIRT-1 | Mean | Standard Deviation | arbitrary units |
|
| SIRT-3 | Mean | Standard Deviation | arbitrary units |
|
| Mitochondrial DNA Content | Mitochondrial DNA content is measured based on the ratio of the mitochondrial genome to nuclear genome ratio (Mt/N) | Mean | Standard Deviation | ratio |
|
| OG001 |
| 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. |
| OG002 | 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. |
|
|
| 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). | Population measured after participant dropout. | Posted | Mean | Standard Deviation | nmol/min/mg/protein | 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). | Posted | Mean | 95% Confidence Interval | nmol/min/mg protein | 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). | Posted | Mean | 95% Confidence Interval | Ratio | Baseline and 90 Days |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | arbitrary units | 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. | Posted | Mean | 95% Confidence Interval | m/s | Baseline to 90 Days |
|
|
|
| Secondary | Blood Glucose Level | Change in levels of blood glucose (metabolic risk factor) from baseline to post-test (90 days). | Posted | Mean | 95% Confidence Interval | mg/dL | 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. | Posted | Mean | Standard Deviation | Counts per minute | 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. | Posted | Mean | Standard Deviation | arbitrary units | 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. | Posted | Mean | 95% Confidence Interval | arbitrary units | 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. | Posted | Mean | 95% Confidence Interval | units on a scale 0-12 | 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. | Posted | Mean | 95% Confidence Interval | arbitrary units | Baseline to 90 days |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 14 |
| 20 |
| EG001 | 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. | 0 | 21 | 0 | 21 | 12 | 21 |
| EG002 | 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. | 0 | 19 | 0 | 19 | 16 | 19 |
| General Issues | General disorders | Systematic Assessment | Patients experiencing adverse events including: low energy, headaches, seasonal allergies |
|
| Muscle soreness, joint inflammation and pain, hand surgery | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bronchitis, conjunctivitis, common cold, bacterial and fungal infections | Infections and infestations | Systematic Assessment |
|
| Increased urination urge, UTI, and kidney stones | Renal and urinary disorders | Systematic Assessment |
|
| Abnormal liver function values | Hepatobiliary disorders | Systematic Assessment |
|
| Tinnitis in ear | Ear and labyrinth disorders | Systematic Assessment |
|
| Significantly low platelet and white blood cell count | Blood and lymphatic system disorders | Systematic Assessment |
|
| Product issue | General disorders | Systematic Assessment | Patient reported feeling a "fullness" in his throat after swallowing pills |
|
| Atrial Fibrillation and irregular heart beat | Cardiac disorders | Systematic Assessment |
|
| Snake Bite | Social circumstances | Systematic Assessment |
|
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D059808 | Polyphenols |
| D010636 | Phenols |
| Male |
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