Resveratrol to Enhance Vitality and Vigor in Elders

NCT02123121 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: IRB201400439 -A -N1R01AT007564-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitochondrial Function; Physical Function

Keywords

Aging; Biogenesis; Cell Respiration; Elderly; Enzymes; Mitochondria; Mitochondrial DNA; Muscle Fatigue; Physical Function; Resveratrol

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (8)

• Change From Baseline in PGC-1α Muscle Protein Levels

  Baseline to 90 Days

• Change From Baseline in Walking Speed.

  Baseline to 90 Days

• Blood Glucose Level

  Baseline to 90 Days

• Physical Activity Levels

  Baseline to 90 Days

• Change From Baseline in AMPK Muscle Protein Levels.

  Baseline to 90 Days

Study Arms (3)

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.

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.

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.

Drug: Resveratrol 1500 mg/day; Other: All groups

Interventions

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.

Resveratrol 1000 mg/day

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.

Resveratrol 1500 mg/day

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.

Also known as: Placebo

Vegetable cellulose

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.

Resveratrol 1000 mg/day; Resveratrol 1500 mg/day; Vegetable cellulose

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Florida: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Office of Dietary Supplements (ODS): collaborator

Study Sites (1)

UF Institute on Aging Clinical and Translational Research Building

Gainesville, Florida, 32611, United States

Location

Related Links

• University of Florida Institute on Aging

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Results Point of Contact

• Title: Dr. Stephen Anton
• Organization: University of Florida

santon@ufl.edu

(352) 273-7514

Study Officials

• Stephen D. Anton, Ph.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2014
• First Posted: April 25, 2014
• Study Start: September 1, 2015
• Primary Completion: May 2, 2019
• Study Completion: May 2, 2019
• Last Updated: April 26, 2024
• Results First Posted: July 27, 2023

Record last verified: 2024-04

Locations

US (1)