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MemoryPhase 1RIPENCT01126229

Resveratrol for Improved Performance in the Elderly

A Phase 1 study testing Low dose Resveratrol and High dose Resveratrol in people with Memory, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Memory
What is being tested?
Low dose Resveratrol and High dose Resveratrol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
Nov 2009to Dec 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
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  • MMSE > 24
  • Non-smoking
  • Telephone Interview for cognitive status (TICS)

Who cannot join

  • 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)
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  • 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;
  • Subject is participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment
  • Current Use of Antidepressant Medications
  • CES-D Score > 20

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Florida, Aging and Geriatric Research

    Gainesville, Florida, 32611

Other trials in United States

About this study

Official title: A Pilot Study of Resveratrol Supplementation for Memory and Physical Performance

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.

Read the detailed description

Enrolled participants will complete psychological questionnaires and a multi-measure cognitive test battery, physical function, as well as provide blood samples, to determine blood chemistry. These will include complete blood count and complete metabolic count [(Na, K, Cl, CO2, BUN, Creatinine, Glucose, Total Protein, Albumin, Calcium, Phosphorous, Aspartate Aminotransferase (AST), Alkaline Phos, Total Bilirubin, and Alanine Amino Transferase (ALT)] and any others deemed necessary by the study physician. They will return to the laboratory to perform a muscular endurance test and MRI evaluation at the Brain Institute. Eligible participants will be randomly assigned with equal probability to either receive resveratrol (300 mg/d or 1000 mg/d) or placebo for twelve weeks. Immediately following completion of the MRI, participants will be given a month's supply of resveratrol or placebo. All participants will be closely monitored for safety and toxicity during the first 10 days (range 8-12 days are acceptable) of the trial. During this initial evaluation period, blood chemistries (complete metabolic profiles) will be evaluated every 3 (range 1-2 days are acceptable) days. Following one month, participants will be asked to return to clinic. At their monthly visits, memory tests, blood samples will be collected to monitor cognitive adaptations and ensure that no adverse changes have occurred. Participants' compliance with the supplementation regimen will also be checked through pill counts, and participants will be given a month's supply of product at each of their monthly visits. After 12 weeks of taking either resveratrol or a placebo on a daily basis, participants will complete a final test battery, an MRI scan, a blood draw collection. A follow-up evaluation will be provided at 10 and 30 days following completion of the final post-treatment assessment.

Conditions
Memory
Being tested
Placebo, Low dose Resveratrol, High dose Resveratrol
Keywords
Resveratrol, Grape, Aging, functional MRI (fMRI), Anti-Aging therapeutic, Oxidative Stress, Functional Performance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDietary supplement

    2 capsules of placebo daily for 12 weeks

  • Low dose ResveratrolDrug

    Also called ReserveAge

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

  • High dose ResveratrolDrug

    Also called ReserveAge

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

Study groups in NCT01126229
Study groupRoleWhat they receive
PlaceboPlacebo comparatorDietary Supplement: placebo
Receives: Dietary Supplement: Placebo
300 mg/d ResveratrolExperimentalDietary Supplement: 300 mg/d Resveratrol
Receives: Drug: Low dose Resveratrol
1000 mg/d ResveratrolExperimentalDietary Supplement: 1000 mg/d Resveratrol
Receives: Drug: High dose Resveratrol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Outcomes

    CBC, Complete Metabolic Panel, Toxicity according to NCI criteria

    Measured: 24 months

Secondary outcomes (2)

  1. Cognitive Outcomes

    Executive function measured by N-back and Controlled Oral Word Association test, Processing Speed measuring by Trails A \& B, Memory Function measured by word recall.

    Measured: 24 months

  2. Physical Outcomes

    Physical function measured by performance on the 400 meter walk test, physical activity levels as measured by accelerometer.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2010 (estimated)
  2. Study startNov 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01126229
Sponsor's protocol ID
238-2009
Acronym
RIPE
Status last verified
Dec 2013
First submitted
17 May 2010
Last updated
11 Dec 2013
Results posted
No

Publications

  • 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.

    PubMed 24866496

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Low dose Resveratrol and High dose Resveratrol in people with Memory, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Outcomes (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01126229, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2013.

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