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The Effect of Dietary Strawberry Supplementation on Older Adults

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by USDA Human Nutrition Research Center on Aging
Sponsor:
Collaborator:
California Strawberry Commission
Information provided by (Responsible Party):
Barbara Shukitt-Hale, USDA Human Nutrition Research Center on Aging
ClinicalTrials.gov Identifier:
NCT02051140
First received: January 29, 2014
Last updated: October 21, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention
Aging
Age-related Memory Disorders
Dietary Supplement: Freeze-dried Strawberry
Dietary Supplement: Strawberry Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Dietary Strawberry Supplementation on Older Adults

Resource links provided by NLM:


Further study details as provided by USDA Human Nutrition Research Center on Aging:

Primary Outcome Measures:
  • Cognition [ Time Frame: Change from baseline at 45 days ] [ Designated as safety issue: No ]
    Spatial memory and learning (virtual water maze); short-term memory (digit span), verbal learning and memory (California verbal learning Test), executive function (trail making test, task switching test), attention (attention network test)

  • Cognition [ Time Frame: Change from baseline at 90 days ] [ Designated as safety issue: No ]
    Spatial memory and learning (virtual water maze); short-term memory (digit span), verbal learning and memory (California verbal learning Test), executive function (trail making test, task switching test), attention (attention network test)


Secondary Outcome Measures:
  • Gait [ Time Frame: Change from baseline at 45 days ] [ Designated as safety issue: No ]
    gait speed, step length variability, step width variability via instrumented treadmill

  • Gait [ Time Frame: Change from baseline at 90 days ] [ Designated as safety issue: No ]
    gait speed, step length variability, step width variability via instrumented treadmill


Other Outcome Measures:
  • Balance [ Time Frame: Change from baseline at 45 days ] [ Designated as safety issue: No ]
    sway velocity and sway area via pressure-sensor

  • Balance [ Time Frame: Change from baseline at 90 days ] [ Designated as safety issue: No ]
    sway velocity and sway area via pressure-sensor


Estimated Enrollment: 44
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Strawberry
Participants randomized into this arm of the study consume freeze-dried strawberry.
Dietary Supplement: Freeze-dried Strawberry
12g freeze-dried strawberry (powder), twice daily with water, for 90 days
Placebo Comparator: Placebo
Participants randomized into this arm of the study consume a strawberry placebo.
Dietary Supplement: Strawberry Placebo
12g blue, strawberry-flavored powder, twice daily with water, for 90 days

Detailed 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.

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women are between the ages of 60 and 75 years
  • Body mass index 18.5-29.9 kg/m2
  • Adequate visual acuity or corrected visual acuity to read and perform computer tasks.
  • Fluency in spoken and written English
  • Ability to walk independently for 20 minutes
  • Absence of menstruation for a minimum of 12 months or surgical menopause.

Exclusion Criteria:

  • Self-reported vegetarian or vegan.
  • Any condition that has resulted in cognitive deficits, including but not limited to - Alzheimer's disease or other dementias, cerebrovascular accident, or head injury
  • History of any neurologic disorder resulting in permanent or relapsing/remitting neurologic impairment including but not limited to Parkinson's disease, amyotrophic lateral sclerosis, Huntington's disease, peripheral neuropathy, or radiculopathy.
  • History of any condition resulting in permanent muscle or mobility deficit that would interfere with walking independent of assistance for 20 minutes, including but not limited to amputation, fracture, arthritis, myopathy, or limb, hip or back surgery within the last year.
  • Self-reported cognitive, memory, neurologic or functional deficits that are stated to interfere with activities of daily living or functional status.
  • Any chronic condition associated with increased risk of falls such as vestibular disease, orthostatic hypotension or neuropathy.
  • Falls within the last year, that occurred in the course or routine daily activities, which were not precipitated by unusual circumstances such as being pushed or falling on ice.
  • Regular use (i.e. that cannot or should not be discontinued for the entire study period, as per the subject's personal physician) of medications or dietary supplements known or suspected to influence cognitive function, attention, ability to ambulate, gait, balance, or risk of falls that in the opinion of the study physician may influence study results or increase risk with participation in the study.
  • Psychiatric disorders that could in the opinion of the study physician interfere with study testing, including bipolar disorder, psychosis, and major depression
  • MMSE score of less than 24 at screening
  • Gastrointestinal disorders that influence digestion and absorption of food
  • Diabetes mellitus
  • Liver dysfunction
  • History of cirrhosis
  • SGPT, SGOT, or total bilirubin > 2 x upper limit of normal
  • Kidney disease as indicated by serum creatinine > 1.5 mg/dL at screening
  • Cardiac or pulmonary conditions that limit ambulation or results in dyspnea with ambulation with walking required as part of activities of daily living.
  • Reported allergy to strawberry or ingredients in the placebo.
  • Ethanol use estimated to be on average > 2 servings/day of beer (12-ounces), wine (5 ounces) or liquor (1.5 ounces), or self-reported binge-drinking.
  • Illicit drug use in the last 12 months.
  • Cigarette smoking within the last 6 months or current use of nicotine.
  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: NCT02051140

Contacts
Contact: Kimberly Dupiton 617-556-3012 Kimberly.Dupiton@tufts.edu

Locations
United States, Massachusetts
Jean Meyer USDA Human Nutrition Research Center on Aging at Tufts University Recruiting
Boston, Massachusetts, United States, 02111
Principal Investigator: Tammy Scott, PhD         
Sub-Investigator: Barbara Shukitt-Hale, PhD         
Sub-Investigator: Marsahll G Miller, MA         
Sponsors and Collaborators
USDA Human Nutrition Research Center on Aging
California Strawberry Commission
Investigators
Principal Investigator: Tammy Scott, PhD Tufts University
Study Director: Barbara Shukitt-Hale, PhD USDA/ARS
  More Information

Additional Information:
Publications:
Responsible Party: Barbara Shukitt-Hale, Research Psychologist, USDA Human Nutrition Research Center on Aging
ClinicalTrials.gov Identifier: NCT02051140     History of Changes
Other Study ID Numbers: ARS-2014-1
Study First Received: January 29, 2014
Last Updated: October 21, 2014
Health Authority: United States: Federal Government

Keywords provided by USDA Human Nutrition Research Center on Aging:
Postural Balance
Walking
Giat
Cognition
Learning
Memory
Antioxidants
Anti-Inflammatory Agents
Brain
Strawberry

Additional relevant MeSH terms:
Memory Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014