Clinical trial
Phase IIa Study of Resveratrol to Enhance Mitochondrial and Physical Function in Older Adults
Name
IRB201400439 -A -N
Description
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.
Trial arms
Trial start
2015-09-01
Estimated PCD
2019-05-02
Trial end
2019-05-02
Status
Completed
Phase
Early phase I
Treatment
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.
Arms:
Resveratrol 1000 mg/day
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.
Arms:
Resveratrol 1500 mg/day
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.
Arms:
Vegetable cellulose
Other names:
Placebo
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.
Arms:
Resveratrol 1000 mg/day, Resveratrol 1500 mg/day, Vegetable cellulose
Size
60
Primary endpoint
Change From Baseline in Mitochondrial Respiration in Muscle
Baseline to 90 Days
Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples
Baseline to 90 days
Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples
Baseline to 90 Days
Change From Baseline in Mitochondrial DNA Content in Muscle Samples
Baseline and 90 Days
Eligibility criteria
Inclusion Criteria:
* Ability to understand study procedures and to comply with them for the entire length of the study;
* Age 65 years and older;
* Moderate to high functioning (i.e. a summary score of 4 - 10 on the Short Physical Performance Battery \[SPPB\]);
* Body Mass Index (BMI) range: 20-39.9 kg/m2;
* Willingness to undergo all testing procedures.
Exclusion Criteria:
* Failure to provide informed consent;
* Allergy/sensitivity to grapes or Japanese knotweed;
* Current dietary supplementation of grape seed extract or ginko biloba;
* Consumption of ≥ 8 oz. of red wine/dealcoholized red wine/red or purple grape juice more than once weekly;
* Consumption of any dietary supplements containing resveratrol, quercetin, or P. cuspidatum in the previous 90 days;
* Active treatment for cancer, stroke (\< 6 months), peripheral vascular disease, coronary artery disease, myocardial infarction (\< 6 months), congestive heart failure (stage III or IV), valvular heart disease, major psychiatric disease, severe anemia (blood levels of Hemoglobin \< 8 g/dl), liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity ( \< 6 months), upper or lower extremity amputation, or Parkinson's disease;
* Cognitive impairment (i.e. Mini Mental Status Exam ≤ 23);
* History of significant head injury;
* Physical activity (i.e. running, bicycling, etc.) ≥ 120 min/week;
* Excessive alcohol use (\> 2 drinks/day) or alcohol abuse (\> 5 drinks/day for males, or \> 4 drinks/day for females);
* History of substance abuse within the past six months;
* Mood disorder (i.e. Center for Epidemiological Studies - Depression (CES-D) ≥ 16);
* History of tobacco use within the past three years;
* Resting heart rate \> 120 bpm at screening visit;
* Systolic blood pressure \> 160 mm Hg at screening visit;
* Diastolic blood pressure \> 90 mm Hg at screening visit;
* Fasting glucose ≥ 126 mg/dL at screening visit;
* Abnormalities in blood chemistry parameters, defined by blood chemistry marker outside of healthy range);
* Current use of anabolic treatments (e.g. growth hormone or testosterone), anticholinesterase inhibitor (e.g. Aricept), hormone replacement (e.g. Estrogen), or anticoagulant therapies (note: aspirin use (≤ 81mg/day) is permitted);
* Participation in another clinical trial, or has received an investigational product within 30 days prior to screening/enrollment;
* Refuse to refrain from CoQ10 or alpha-lipoic acid while enrolled in the study.
Temporary Exclusion Criteria
* Recent bacterial/viral infection (\< 2 weeks);
* Acute febrile illness in past 2 months;
* High blood pressure (i.e. ≥ 140/90 mm Hg but ≤ 160/90) at the screening visit;
* Major surgery or hip/knee replacement (\< 6 months).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}
Updated at
2024-04-26
1 organization
1 product
2 indications
Organization
University of FloridaProduct
ResveratrolIndication
Mitochondrial FunctionIndication
Physical Function