Resveratrol to Enhance Vitality and Vigor in Elders (REVIVE)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by University of Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT02123121
First received: April 21, 2014
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Mitochondrial Function
Physical Function
Drug: Resveratrol 1000 mg/day
Drug: Resveratrol 1500 mg/day
Other: Vegetable cellulose
Other: All groups
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase IIa Study of Resveratrol to Enhance Mitochondrial and Physical Function in Older Adults

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • Change from Baseline in mitochondrial respiration in muscle [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Mitochondrial respiration (State 3) in muscle samples of moderate-to-low functioning older adults.

  • Change from baseline in cytochrome oxidase (COX) in muscle samples [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Cytochrome oxidase (COX) in muscle samples of moderate-to-low functioning in older adults.

  • Change from baseline in citrate synthase (CS) enzymes in muscle samples [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Citrate synthase (CS) enzymes in muscle samples of moderate-to-low functioning in older adults.

  • Change from baseline in mitochondrial DNA content in muscle samples [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Mitochondrial DNA content in muscle samples of moderate-to-low functioning in older adults.


Secondary Outcome Measures:
  • Change from Baseline in PGC-1α muscle protein levels [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Muscle protein levels, such as PGC-1α (primary outcome) in muscle samples of moderate-to-low functioning older adults..

  • Change from Baseline in walking speed. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Physical function, such as walking speed.

  • Change from Baseline in blood level glucose [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Blood level glucose (metabolic risk factor)

  • Change from Baseline in blood level of insulin [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Blood level of insulin (metabolic risk factor)

  • Change from Baseline in diastolic blood pressure [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Diastolic blood pressure (metabolic risk factors)

  • Change from Baseline in physical activity levels [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Levels of spontaneous physical activity

  • Change from Baseline in AMPK muscle protein levels. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Muscle protein levels, such as AMPK in muscle samples of moderate-to-low functioning older adults.

  • Change from Baseline in sirtuins muscle protein levels. [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Muscle protein levels, such as sirtuins (SIRT1 and SIRT3), in muscle samples of moderate-to-low functioning older adults.

  • Change from Baseline in physical performance [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    physical performance.

  • Change from Baseline in resistance to muscle fatigue [ Time Frame: 90 Days ] [ Designated as safety issue: No ]
    Resistance to muscle fatigue.


Estimated Enrollment: 60
Study Start Date: September 2014
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Other: 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.
Other Name: Placebo
Other: 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.
Active Comparator: 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.
Drug: 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.
Other: 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.
Active Comparator: 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.
Drug: 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.
Other: 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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to understand study procedures and to comply with them for the entire length of the study;
  • Age 70 years and older;
  • Mild-to-moderate physical impairment (i.e. a summary score of 4 - 10 on the Short Physical Performance Battery [SPPB]);
  • Body Mass Index (BMI) range: 20-29.9 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02123121

Contacts
Contact: Stephen Anton, PhD 352-273-7514 santon@ufl.edu
Contact: Megan Lorow 352-294-5090 mlorow@ufl.edu

Locations
United States, Florida
UF Institute on Aging Clinical and Translational Research Building Not yet recruiting
Gainesville, Florida, United States, 32611
Contact: Stephen Anton, PhD    352-273-7514    santon@ufl.edu   
Contact: Megan Lorow    352-273-9212    mlorow@ufl.edu   
Principal Investigator: Stephen Anton, PhD         
Sub-Investigator: Christiaan Leeuwenburgh, PhD         
Sub-Investigator: Todd Manini, PhD         
Sub-Investigator: Anna-Maria Joseph, PhD         
Sub-Investigator: Michael Marsiske, PhD         
Sub-Investigator: Jonathan Shuster, PhD         
Sub-Investigator: Bhanuprasad Sandesara, MD         
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Stephen D. Anton, Ph.D. University of Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02123121     History of Changes
Other Study ID Numbers: 1R01AT007564-01A1, 1R01AT007564-01
Study First Received: April 21, 2014
Last Updated: April 23, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Florida:
Aging
Biogenesis
Cell Respiration
Elderly
Enzymes
Mitochondria
Mitochondrial DNA
Muscle Fatigue
Physical Function
Resveratrol

Additional relevant MeSH terms:
Resveratrol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents
Antimutagenic Agents
Anticarcinogenic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014