Effects of Blueberry on Cognition and Mobility in Older Adults

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
U.S. Highbush Blueberry Council
Tufts University
Information provided by (Responsible Party):
Barbara Shukitt-Hale, USDA Human Nutrition Research Center on Aging
ClinicalTrials.gov Identifier:
NCT01888848
First received: June 13, 2013
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Aging
Age-Related Memory Disorders
Dietary Supplement: Freeze-dried Blueberry
Dietary Supplement: Blueberry 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: Effects of Dietary Blueberry Supplementation on Cognition and Mobility in Healthy 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 (Morris 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 (Morris 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 90 days ] [ Designated as safety issue: No ]
    gait speed, step length variability, step width variability via instrumented treadmill

  • 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


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: 40
Study Start Date: January 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: blueberry
Participants randomized into this arm of the study consume freeze-dried blueberry.
Dietary Supplement: Freeze-dried Blueberry
12g freeze-dried blueberry (powder), twice daily with water, for 90 days
Placebo Comparator: placebo
Participants randomized into this arm of the study consume a blueberry placebo.
Dietary Supplement: Blueberry Placebo
12g blue, blueberry-flavored powder, twice daily with water, for 90 days

Detailed Description:

This study is being conducted to assess the effect of dietary blueberry 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 blueberry powder or a placebo powder that tastes like blueberry. 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 blueberry 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: NCT01888848

Locations
United States, Massachusetts
Jean Meyer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
USDA Human Nutrition Research Center on Aging
U.S. Highbush Blueberry Council
Tufts University
Investigators
Principal Investigator: Edward Saltzman, MD 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: NCT01888848     History of Changes
Other Study ID Numbers: USDAHNRC-2013-1, 1950-51000-070-19R
Study First Received: June 13, 2013
Last Updated: January 29, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 16, 2014