The Effect of Dietary Strawberry Supplementation on Older Adults

Status Completed

Clinical Trial Summary

This study is being conducted to assess the effect of dietary strawberry supplementation on cognition and mobility in older adults. It is hypothesized that plant compounds, present in strawberries, may improve cognition and mobility by protecting against oxidative stress and inflammation.

Clinical Trial Description

This study is being conducted to assess the effect of dietary strawberry supplementation vs. placebo on measures of cognition and mobility in older adults. Participants will visit the HNRCA on 4 occasions. During the first visit, participants will complete a dietary assessment and familiarize themselves with some of the cognitive tests used in the study. After a period of up to 45 days participants will return for the second visit. Participants will be randomized to consume either freeze dried strawberry powder or a placebo powder that tastes like strawberry. At visits 2, 3 and 4, participants will undergo tests of cognition, memory, gait and balance. In addition, blood samples and 24-hour urine will be collected at these visits. Tests include balance and gait assessment using a treadmill instrumented with pressure sensors which will measure postural sway and a variety of spatial/temporal gait parameters. Participants will also be affixed with surface electrodes to measure the activation of muscles in their legs during these balance and gait measurements. Participants will complete a battery of cognitive tests on paper and by computer. In the time between participants' visit 2 and visit 4, participants will receive a weekly telephone call to check in with them and remind them to continue taking the study powder. At the very end of the study, when all participants are finished, participants will receive a telephone call to debrief them and notify them which group they were randomized into. An optional tissue banking protocol will be offered for collection of additional blood to be banked at visits 2-4. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02051140
Study type	Interventional
Source	USDA Human Nutrition Research Center on Aging
Contact
Status	Completed
Phase	N/A
Start date	May 2014
Completion date	August 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.