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The Effect of Dietary Strawberry Supplementation on Older Adults

Primary Purpose

Aging, Age-related Memory Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freeze-dried Strawberry
Strawberry Placebo
Sponsored by
USDA Human Nutrition Research Center on Aging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aging focused on measuring Postural Balance, Walking, Giat, Cognition, Learning, Memory, Antioxidants, Anti-Inflammatory Agents, Brain, Strawberry

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 strawberry 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Strawberry

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Gait
gait speed, step length variability, step width variability via instrumented treadmill
Gait
gait speed, step length variability, step width variability via instrumented treadmill

Full Information

First Posted
January 29, 2014
Last Updated
September 1, 2015
Sponsor
USDA Human Nutrition Research Center on Aging
Collaborators
California Strawberry Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02051140
Brief Title
The Effect of Dietary Strawberry Supplementation on Older Adults
Official Title
The Effect of Dietary Strawberry Supplementation on Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Human Nutrition Research Center on Aging
Collaborators
California Strawberry Commission

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study is being conducted to assess the effect of dietary strawberry 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 strawberry powder or a placebo powder that tastes like strawberry. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Age-related Memory Disorders
Keywords
Postural Balance, Walking, Giat, Cognition, Learning, Memory, Antioxidants, Anti-Inflammatory Agents, Brain, Strawberry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Strawberry
Arm Type
Experimental
Arm Description
Participants randomized into this arm of the study consume freeze-dried strawberry.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized into this arm of the study consume a strawberry placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Freeze-dried Strawberry
Intervention Description
12g freeze-dried strawberry (powder), twice daily with water, for 90 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Strawberry Placebo
Intervention Description
12g blue, strawberry-flavored powder, twice daily with water, for 90 days
Primary Outcome Measure Information:
Title
Cognition
Description
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)
Time Frame
Change from baseline at 45 days
Title
Cognition
Description
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)
Time Frame
Change from baseline at 90 days
Secondary Outcome Measure Information:
Title
Gait
Description
gait speed, step length variability, step width variability via instrumented treadmill
Time Frame
Change from baseline at 45 days
Title
Gait
Description
gait speed, step length variability, step width variability via instrumented treadmill
Time Frame
Change from baseline at 90 days
Other Pre-specified Outcome Measures:
Title
Balance
Description
sway velocity and sway area via pressure-sensor
Time Frame
Change from baseline at 45 days
Title
Balance
Description
sway velocity and sway area via pressure-sensor
Time Frame
Change from baseline at 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 strawberry 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy Scott, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Shukitt-Hale, PhD
Organizational Affiliation
USDA/ARS
Official's Role
Study Director
Facility Information:
Facility Name
Jean Meyer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22264107
Citation
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.
Results Reference
background
PubMed Identifier
10479711
Citation
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.
Results Reference
background
Links:
URL
http://hnrca.tufts.edu/
Description
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
URL
http://www.ars.usda.gov/main/main.htm
Description
Agricultural Research Service (USDA)
URL
http://www.calstrawberry.com/
Description
California Strawberry Commission

Learn more about this trial

The Effect of Dietary Strawberry Supplementation on Older Adults

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