The Effects of Strawberry Supplementation on Memory and Gait Among Over-weight Older Adults
1 other identifier
interventional
47
1 country
1
Brief Summary
This study is being conducted to assess the effect of dietary strawberry supplementation on cognition and mobility in obese middle-aged and older adults. It is hypothesized that plant compounds, present in strawberries, may improve cognition and mobility.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2017
Longer than P75 for not_applicable
1 active site
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
May 19, 2017
CompletedFirst Posted
Study publicly available on registry
May 22, 2017
CompletedStudy Start
First participant enrolled
October 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2023
CompletedMarch 28, 2024
March 1, 2024
6.1 years
May 19, 2017
March 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spatial Cognition
Spatial cognition will be measured using a virtual navigation task.
Change from baseline at 90 days
Secondary Outcomes (1)
Gait Speed
Change from baseline at 90 days
Study Arms (2)
Strawberry
EXPERIMENTALParticipants randomized into this arm of the study consume freeze-dried strawberry powder.
Placebo
PLACEBO COMPARATORParticipants randomized into this arm of the study consume a strawberry placebo powder.
Interventions
12g freeze-dried strawberry (powder), twice daily with water, for 90 days
Eligibility Criteria
You may qualify if:
- Between the ages of 55 and 75 years
- Body mass index (BMI) between 30-40
- Hemoglobin A1C level between 5.7 and 6.4%
- Height between 60 and 74 inches tall
- 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 as per self-report.
- Women must be postmenopausal (absence of menstruation for a minimum of 12-months or bilateral oophorectomy)
- Willing to abstain from recreational drug use
You may not qualify if:
- Vegetarian or vegan
- Cognitive impairment, memory loss, or neurologic/psychological disorder that interfere with activities of daily living
- Muscle or mobility deficit that would interfere with walking independent for 20 minutes
- Chronic conditions associated with increased risk of falls or falls within the last year that were not precipitated by unusual circumstances (e.g. slipping on ice, being pushed)
- Gastrointestinal diseases, conditions, or medications influencing gastrointestinal absorption
- Use of medications or dietary supplements known or suspected to influence study outcomes
- Mini Mental State Exam (MMSE) score of less than 24 at screening
- Diabetes mellitus diagnosis or fasting glucose \>= 126 mg/dL or taking diabetes medication
- Liver dysfunction, history of cirrhosis, or elevated SGPT, SGOT, or total bilirubin
- Kidney disease as indicated by serum creatinine \> 1.5 mg/dL at screening
- Uncontrolled blood pressure
- Cardiac or pulmonary conditions that limit ambulation or results in dyspnea with ambulation
- Allergy to strawberry or ingredients in the placebo.
- Ethanol use above 2 servings/day of beer (12-ounces), wine (5 ounces) or liquor (1.5 ounces), or binge-drinking
- Recent inflammatory diseases (for example: rheumatoid arthritis, lupus)
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tammy M Scott
Boston, Massachusetts, 02111, United States
Related Publications (4)
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: 22264107BACKGROUNDJoseph 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: 10479711BACKGROUNDMiller MG, Thangthaeng N, Poulose SM, Shukitt-Hale B. Role of fruits, nuts, and vegetables in maintaining cognitive health. Exp Gerontol. 2017 Aug;94:24-28. doi: 10.1016/j.exger.2016.12.014. Epub 2016 Dec 21.
PMID: 28011241BACKGROUNDShukitt-Hale B, Bielinski DF, Lau FC, Willis LM, Carey AN, Joseph JA. The beneficial effects of berries on cognition, motor behaviour and neuronal function in ageing. Br J Nutr. 2015 Nov 28;114(10):1542-9. doi: 10.1017/S0007114515003451. Epub 2015 Sep 22.
PMID: 26392037BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tammy M Scott, PhD
Tufts University
- PRINCIPAL INVESTIGATOR
Barbara Shukitt-Hale, PhD
USDA Human Nutrition Research Center on Aging
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Psychologist
Study Record Dates
First Submitted
May 19, 2017
First Posted
May 22, 2017
Study Start
October 1, 2017
Primary Completion
October 20, 2023
Study Completion
October 20, 2023
Last Updated
March 28, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share