NCT02051140

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 2, 2015

Status Verified

September 1, 2015

Enrollment Period

1.3 years

First QC Date

January 29, 2014

Last Update Submit

September 1, 2015

Conditions

AgingAge-related Memory Disorders

Keywords

Postural BalanceWalkingGiatCognitionLearningMemoryAntioxidantsAnti-Inflammatory AgentsBrainStrawberry

Outcome Measures

Primary Outcomes (2)

  • Cognition

    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)

    Change from baseline at 45 days

  • Cognition

    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)

    Change from baseline at 90 days

Secondary Outcomes (2)

  • Gait

    Change from baseline at 45 days

  • Gait

    Change from baseline at 90 days

Other Outcomes (2)

  • Balance

    Change from baseline at 45 days

  • Balance

    Change from baseline at 90 days

Study Arms (2)

Strawberry

EXPERIMENTAL

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

Dietary Supplement: Freeze-dried Strawberry

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Strawberry Placebo

Interventions

Freeze-dried StrawberryDIETARY_SUPPLEMENT

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

Strawberry
Strawberry PlaceboDIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

  • 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: 22264107BACKGROUND

  • 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: 10479711BACKGROUND

Related Links

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tammy Scott, PhD

    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

January 29, 2014

First Posted

January 31, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 2, 2015

Record last verified: 2015-09

Locations

US(1)