Resveratrol for Improved Performance in the Elderly

NCT01126229 | Completed Phase 1

• 1 other identifier: 238-2009
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim to conduct a randomized placebo controlled pilot study to determine whether resveratrol, a dietary ingredient, supplementation is safe and improves memory and physical performance in older adults. Loss in memory and physical performance is a frequent complaint in older adults and a growing public health issue. Additionally, later adulthood is associated with a normative decline in both working and primary memory as well as domains including attention, speed of processing and executive function. Resveratrol is safely tolerated in pre-clinical models and in dose-escalation human studies. It also has demonstrated beneficial effects on memory and performance in pre-clinical models. Therefore, this study will take the next step in understanding the longer-term safety (3 months) and efficacy of resveratrol supplementation on age-related health conditions.

Conditions

Memory

Keywords

Resveratrol; Grape; Aging; functional MRI (fMRI); Anti-Aging therapeutic; Oxidative Stress; Functional Performance

Outcome Measures

Primary Outcomes (1)

• Safety Outcomes

  CBC, Complete Metabolic Panel, Toxicity according to NCI criteria

  24 months

Secondary Outcomes (2)

• Cognitive Outcomes

  24 months

• Physical Outcomes

  24 months

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Dietary Supplement: placebo

Dietary Supplement: Placebo

300 mg/d Resveratrol

EXPERIMENTAL

Dietary Supplement: 300 mg/d Resveratrol

Drug: Low dose Resveratrol

1000 mg/d Resveratrol

EXPERIMENTAL

Dietary Supplement: 1000 mg/d Resveratrol

Drug: High dose Resveratrol

Interventions

Placebo DIETARY_SUPPLEMENT

2 capsules of placebo daily for 12 weeks

Placebo

Low dose Resveratrol DRUG

2 capsules daily for 12 weeks containing 300 mg/d (combined) of resveratrol active ingredient

Also known as: ReserveAge

300 mg/d Resveratrol

High dose Resveratrol DRUG

2 capsules daily for 12 weeks containing 1000 mg/d (combined) of resveratrol active ingredient

Also known as: ReserveAge

1000 mg/d Resveratrol

Eligibility Criteria

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

You may qualify if:

• Men and women aged 65-100 years
• Body mass index \> = 25 and \< = 35
• Willing and able to participate in all aspects of the study
• Willing to be randomized to either treatment group
• Sedentary to moderately active lifestyle (\<120 min aerobic activity/week)
• Report of ability to walk one mile
• MMSE \> 24
• Non-smoking
• Telephone Interview for cognitive status (TICS)

You may not qualify if:

• Active treatment for cancer, stroke (\< 6 mo), peripheral vascular disease, coronary artery disease (myocardial infarction \<6 mo), state III, IV Congestive Heart Failure, valvular heart disease, major psychiatric disease, severe anemia, liver or renal disease, diabetes, severe osteoarthritis, blindness or deafness, fracture in upper or lower extremity within the last 6 months, upper or lower extremity amputation, anticoagulant therapy (aspirin use is permitted), parkinsons disease
• Failure to give consent
• Anabolic medications (growth hormone or testosterone)
• High amounts of physical activity (i.e. running, bicycling etc) \> 120 min/week.
• Dementing illness
• Excessive alcohol use (\>2 drinks per day)
• Resting heart rate \> 120 bpm
• Systolic blood pressure \> 180 mmHg
• Diastolic blood pressure \> 100 mmHg
• Dietary supplementation of grape seed extract or ginko biloba
• History of significant head injury
• Vision or hearing impairment
• Anticholinesterase inhibitor (such as Aricept)
• Contraindications to MRI (e.g. cardiac pacemaker, implanted cardiac defibrillator, aneurysm clip, claustrophobia, etc.)
• Consumption 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;

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida, Aging and Geriatric Research

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• Anton SD, Embry C, Marsiske M, Lu X, Doss H, Leeuwenburgh C, Manini TM. Safety and metabolic outcomes of resveratrol supplementation in older adults: results of a twelve-week, placebo-controlled pilot study. Exp Gerontol. 2014 Sep;57:181-7. doi: 10.1016/j.exger.2014.05.015. Epub 2014 May 24.

  PMID: 24866496 DERIVED

MeSH Terms

Interventions

Resveratrol

Intervention Hierarchy (Ancestors)

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

Study Officials

• Todd M. Manini, PhD

  University of Florida, Aging and Geriatric Research

  PRINCIPAL INVESTIGATOR

• Stephen M Manini, PhD

  University of Florida, Aging and Geriatric Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 19, 2010
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 11, 2013

Record last verified: 2013-12

Locations

US (1)