Mitochondrial FunctionPhase 2REVIVENCT02123121
Resveratrol to Enhance Vitality and Vigor in Elders
A Phase 2 study testing Resveratrol 1000 mg/day, Resveratrol 1500 mg/day and Vegetable cellulose in people with Mitochondrial Function and Physical Function, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial Function, Physical Function
- What is being tested?
- Resveratrol 1000 mg/day, Resveratrol 1500 mg/day and Vegetable cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to 2 May 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 26Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Institute on Aging Clinical and Translational Research Building
Gainesville, Florida, 32611
About this study
Official title: Phase IIa Study of Resveratrol to Enhance Mitochondrial and Physical Function in Older Adults
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.
Read the 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:
- 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:
- Walking at the usual pace for a distance of 13 feet (4 meters) two (2) separate times
- 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.
- 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:
- 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:
- Walking as fast and far as the subject can for 6 minutes
- Walking at subject's usual pace for a distance of 13 feet (4 meters) two (2) separate times
- 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.
- Maintaining balance while standing in three (3) different positions.
- Assessment of lower-body muscle strength and endurance
- 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:
- Collection of fasting blood samples
- Measurement of pulse and blood pressure
- Measurement of weight and waist circumference
- Update medical history and ask questions about any adverse experiences the subject may have had since the last visit
- Counting of any remaining study drug capsules that were not taken since last visit
- 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:
- 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:
- Walking as fast and far as possible for 6 minutes
- Walking at usual pace for a distance of 13 feet (4 meters) two (2) separate times
- 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.
- Maintaining balance while standing in three (3) different positions.
- Assessment of lower-body muscle strength and endurance
- 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.
- Procedure to collect muscle tissue sample (as described in Baseline 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
- Measurement of pulse and blood pressure
- Collection of fasting blood samples
- Update medical history and ask questions about any adverse experiences the subject may have had since last visit
- Conditions
- Mitochondrial Function, Physical Function
- Being tested
- Resveratrol 1000 mg/day, Resveratrol 1500 mg/day, Vegetable cellulose, All groups
- Keywords
- Aging, Biogenesis, Cell Respiration, Elderly, Enzymes, Mitochondria, Mitochondrial DNA, Muscle Fatigue, Physical Function, Resveratrol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resveratrol 1000 mg/dayDrug
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.
Resveratrol 1500 mg/dayDrug
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 celluloseOther
Also called Placebo
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 groupsOther
All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Vegetable cellulose; Other: All groups |
| 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. Receives: Drug: Resveratrol 1000 mg/day; Other: All groups |
| 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. Receives: Drug: Resveratrol 1500 mg/day; Other: All groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline and 90 Days
Secondary outcomes (8)
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.
Measured: Baseline to 90 Days
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.
Measured: Baseline to 90 Days
Blood Glucose Level
Change in levels of blood glucose (metabolic risk factor) from baseline to post-test (90 days).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2014 (estimated)
- Study startSep 2015
- Primary completion2 May 2019
- Study completion2 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mitochondrial FunctionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Responsible party
- Sponsor
- Investigators
- Stephen D. Anton, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123121
- Sponsor's protocol ID
- IRB201400439 -A -N
- Other IDs
- 1R01AT007564-01
- Acronym
- REVIVE
- Status last verified
- Apr 2024
- First submitted
- 21 Apr 2014
- Last updated
- 26 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Study of Resveratrol to Enhance Mitochondrial and Physical Function in Older Adults
- ClinicalTrials.gov ID
- NCT02123121
- Acronym / sponsor ID
- REVIVE / IRB201400439 -A -N
- Conditions
- Mitochondrial Function, Physical Function
- Keywords
- Aging, Biogenesis, Cell Respiration, Elderly, Enzymes, Mitochondria, Mitochondrial DNA, Muscle Fatigue
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Office of Dietary Supplements (ODS)
- Study start
- Sep 2015
- Primary completion
- 2 May 2019 (actual)
- Study completion
- 2 May 2019 (actual)
- First posted
- 25 Apr 2014 (estimated)
- Results
- Posted 27 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Walking at the usual pace for a distance of 13 feet (4 meters) two (2) separate times
- 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.
- 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:
- 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:
- Walking as fast and far as the subject can for 6 minutes
- Walking at subject's usual pace for a distance of 13 feet (4 meters) two (2) separate times
- 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.
- Maintaining balance while standing in three (3) different positions.
- Assessment of lower-body muscle strength and endurance
- 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:
- Collection of fasting blood samples
- Measurement of pulse and blood pressure
- Measurement of weight and waist circumference
- Update medical history and ask questions about any adverse experiences the subject may have had since the last visit
- Counting of any remaining study drug capsules that were not taken since last visit
- 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:
- 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:
- Walking as fast and far as possible for 6 minutes
- Walking at usual pace for a distance of 13 feet (4 meters) two (2) separate times
- 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.
- Maintaining balance while standing in three (3) different positions.
- Assessment of lower-body muscle strength and endurance
- 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.
- Procedure to collect muscle tissue sample (as described in Baseline 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
- Measurement of pulse and blood pressure
- Collection of fasting blood samples
- Update medical history and ask questions about any adverse experiences the subject may have had since last visit
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vegetable cellulose | Placebo comparator | Other: Vegetable cellulose, Other: All groupsParticipants 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 | Drug: Resveratrol 1000 mg/day, Other: All groupsParticipants 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 | Drug: Resveratrol 1500 mg/day, Other: All groupsParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resveratrol 1000 mg/dayOrally 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. | Drug | Resveratrol 1000 mg/day |
| Resveratrol 1500 mg/dayOrally 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. | Drug | Resveratrol 1500 mg/day |
| Vegetable celluloseAlso: PlaceboOrally 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. | Other | Vegetable cellulose |
| All groupsAll Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples. | Other | Resveratrol 1000 mg/day, Resveratrol 1500 mg/day, Vegetable cellulose |
Primary outcome
Change From Baseline in Mitochondrial Respiration in Muscle
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
8 secondary outcomes
Change From Baseline in PGC-1α Muscle Protein Levels
Time frame: Baseline to 90 Days
Change From Baseline in Walking Speed.
Time frame: Baseline to 90 Days
Blood Glucose Level
Time frame: Baseline to 90 Days
Physical Activity Levels
Time frame: Baseline to 90 Days
Change From Baseline in AMPK Muscle Protein Levels.
Time frame: Baseline to 90 Days
Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels.
Time frame: Baseline to 90 Days
Change From Baseline in Physical Performance
Time frame: Baseline to 90 Days
Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels.
Time frame: Baseline to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Florida Institute on AgingLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen D. Anton, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Resveratrol 1000 mg/day, Resveratrol 1500 mg/day and Vegetable cellulose in people with Mitochondrial Function and Physical Function, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Mitochondrial Respiration in Muscle (time frame: Baseline to 90 Days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2024.