Phase 2 N=60 Randomized Double-blind Supportive Care

Resveratrol to Enhance Vitality and Vigor in Elders

Mitochondrial Function · Physical Function

Bottom Line

View on ClinicalTrials.gov: NCT02123121 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2023

Primary outcome: Primary: Change From Baseline in Mitochondrial Respiration in Muscle — -3.05; -4.82; -4.56 nmol O2/s/mg wwt

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Resveratrol 1000 mg/day (Drug); Resveratrol 1500 mg/day (Drug); Vegetable cellulose (Other); All groups (Other)
Age: Older Adult · 65+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: May 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mitochondrial Respiration in Muscle	-3.05; -4.82; -4.56	—
PRIMARY Change From Baseline in Cytochrome Oxidase (COX) in Muscle Samples	109.4; 126.7; 121.2	—
PRIMARY Change From Baseline in Citrate Synthase (CS) Enzymes in Muscle Samples	-0.02; 0.08; -0.09	—
PRIMARY Change From Baseline in Mitochondrial DNA Content in Muscle Samples	2.71; 7.13; -7.31	—
SECONDARY Change From Baseline in PGC-1α Muscle Protein Levels	-0.10; -0.12; -0.07	—
SECONDARY Change From Baseline in Walking Speed.	0.03; 0.06; 0.04	—
SECONDARY Blood Glucose Level	9.49; 0.74; 2.94	—
SECONDARY Physical Activity Levels	167.0; 153.1; 170.9	—
SECONDARY Change From Baseline in AMPK Muscle Protein Levels.	0.42; 0.72; 1.50	—
SECONDARY Change From Baseline in Sirtuins (SIRT1) Muscle Protein Levels.	0.03; 0.00; 0.01	—
SECONDARY Change From Baseline in Physical Performance	0.18; -0.08; 0.06	—
SECONDARY Change From Baseline in Sirtuins (SIRT3) Muscle Protein Levels.	0.01; 0.01; -0.01	—

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.

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 ( 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02123121). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.