Effects of Blueberry on Cognition and Mobility in Older Adults

NCT ID: NCT01888848

Last Updated: 2015-05-27

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aging Age-Related Memory Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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blueberry

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

Group Type EXPERIMENTAL

Freeze-dried Blueberry

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type PLACEBO_COMPARATOR

Blueberry Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Blueberry Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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U.S. Highbush Blueberry Council

OTHER

Sponsor Role collaborator

Tufts University

OTHER

Sponsor Role collaborator

USDA Human Nutrition Research Center on Aging

FED

Sponsor Role lead

Responsible Party

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Barbara Shukitt-Hale

Research Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

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.

Reference Type BACKGROUND
PMID: 22264107 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10479711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20047325 (View on PubMed)

Related Links

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http://hnrca.tufts.edu/

Human Nutrition Research Center on Aging at Tufts University website

http://www.blueberry.org/

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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