Effects of Blueberry on Cognition and Mobility in Older Adults
NCT ID: NCT01888848
Last Updated: 2015-05-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2013-01-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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blueberry
Participants randomized into this arm of the study consume freeze-dried blueberry.
Freeze-dried Blueberry
12g freeze-dried blueberry (powder), twice daily with water, for 90 days
placebo
Participants randomized into this arm of the study consume a blueberry placebo.
Blueberry Placebo
12g blue, blueberry-flavored powder, twice daily with water, for 90 days
Interventions
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Freeze-dried Blueberry
12g freeze-dried blueberry (powder), twice daily with water, for 90 days
Blueberry Placebo
12g blue, blueberry-flavored powder, twice daily with water, for 90 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
75 Years
ALL
Yes
Sponsors
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U.S. Highbush Blueberry Council
OTHER
Tufts University
OTHER
USDA Human Nutrition Research Center on Aging
FED
Responsible Party
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Barbara Shukitt-Hale
Research Psychologist
Principal Investigators
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Edward Saltzman, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts University
Barbara Shukitt-Hale, PhD
Role: STUDY_DIRECTOR
United States Department of Agriculture (USDA)
Locations
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Jean Meyer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, United States
Countries
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References
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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.
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.
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.
Related Links
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Human Nutrition Research Center on Aging at Tufts University website
USDA ARS website
US Highbush Blueberry Council website
Other Identifiers
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1950-51000-070-19R
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
USDAHNRC-2013-1
Identifier Type: -
Identifier Source: org_study_id
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