Effects of Blueberry on Cognition and Mobility in Older Adults

NCT01888848 | Completed

• 2 other identifiers: USDAHNRC-2013-11950-51000-070-19R
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging; Age-Related Memory Disorders

Keywords

Postural Balance; Walking; Gait; Cognition; Learning; Memory; Blueberry; Antioxidants; Anti-Inflammatory Agents; Brain

Outcome Measures

Primary Outcomes (2)

• cognition

  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)

  change from baseline at 45 days

• cognition

  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)

  Change from baseline at 90 days

Secondary Outcomes (2)

• Gait

  Change from baseline at 90 days

• Gait

  Change from baseline at 45 days

Other Outcomes (2)

• Balance

  Change from baseline at 45 days

• Balance

  Change from baseline at 90 days

Study Arms (2)

blueberry

EXPERIMENTAL

Participants randomized into this arm of the study consume freeze-dried blueberry.

Dietary Supplement: Freeze-dried Blueberry

placebo

PLACEBO COMPARATOR

Participants randomized into this arm of the study consume a blueberry placebo.

Dietary Supplement: Blueberry Placebo

Interventions

Freeze-dried Blueberry DIETARY_SUPPLEMENT

12g freeze-dried blueberry (powder), twice daily with water, for 90 days

blueberry

Blueberry Placebo DIETARY_SUPPLEMENT

12g blue, blueberry-flavored powder, twice daily with water, for 90 days

placebo

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• USDA Human Nutrition Research Center on Aging: lead
• U.S. Highbush Blueberry Council: collaborator
• Tufts University: collaborator

Study Sites (1)

Jean Meyer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

Related Publications (3)

• Miller MG, Shukitt-Hale B. Berry fruit enhances beneficial signaling in the brain. J Agric Food Chem. 2012 Jun 13;60(23):5709-15. doi: 10.1021/jf2036033. Epub 2012 Feb 3.

  PMID: 22264107 BACKGROUND

• Joseph JA, Shukitt-Hale B, Denisova NA, Bielinski D, Martin A, McEwen JJ, Bickford PC. Reversals of age-related declines in neuronal signal transduction, cognitive, and motor behavioral deficits with blueberry, spinach, or strawberry dietary supplementation. J Neurosci. 1999 Sep 15;19(18):8114-21. doi: 10.1523/JNEUROSCI.19-18-08114.1999.

  PMID: 10479711 BACKGROUND

• Krikorian R, Shidler MD, Nash TA, Kalt W, Vinqvist-Tymchuk MR, Shukitt-Hale B, Joseph JA. Blueberry supplementation improves memory in older adults. J Agric Food Chem. 2010 Apr 14;58(7):3996-4000. doi: 10.1021/jf9029332.

  PMID: 20047325 BACKGROUND

Related Links

• Human Nutrition Research Center on Aging at Tufts University website
• USDA ARS website
• US Highbush Blueberry Council website

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Saltzman, MD

  Tufts University

  PRINCIPAL INVESTIGATOR

• Barbara Shukitt-Hale, PhD

  United States Department of Agriculture (USDA)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 28, 2013
• Study Start: January 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2015-05

Locations

US (1)