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CompletedNCT03162913Updated Mar 28, 2024

The Effects of Strawberry Supplementation on Memory and Gait Among Over-weight Older Adults

An interventional study of Strawberry and Placebo in Aging, Age-related Cognitive Decline and Obesity, sponsored by USDA Human Nutrition Research Center on Aging. Completed at 1 site in United States. Open to participants aged 55 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-28.

Sponsored by USDA Human Nutrition Research Center on Aging · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
47
Allocation
Randomized
Ages
55 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

Previously, the investigators have shown that dietary berry fruit are able to reverse several parameters of brain aging, as well as age-related motor and cognitive deficits when fed to aged rats. They have shown that strawberry, in particular, can reduce oxidative stress and pro-inflammatory signaling in the brain and improve both mobility and cognition. A recent study also found that the addition of two servings of strawberry per day for 3 months could significantly improve verbal and spatial memory among healthy older adults, particularly on tests with high cognitive demand. These effects may reflect the direct effects of strawberries' bioactive and neuroavailable polyphenols on brain signaling or their indirect effects through antioxidant and anti-inflammatory pathways. However, participants in that study were selected from a healthy aging population, which made it difficult to detect changes in balance, mobility, and the less complex cognitive tasks. Therefore, the investigators are proposing the current study to assess the effects of dietary strawberry on mobility and cognition among a compromised population, obese older adults, who are at increased risk for cardiovascular, metabolic, and neurodegenerative disease. The risk for heart disease, diabetes, stroke, cancer and dementia increases in direct relation to overweight and obesity measures, and research now shows that obesity is a primary cause of mental deterioration among the middle-aged and senior populations. In this study, obese older adults (55-75yo, BMI 30-36) will consume 24g/d freeze-dried strawberry or control powder for 3 months and complete a battery of lifestyle, mobility, and cognitive tests at 3 time points. The investigators hypothesize that supplementing obese older adults' diet with strawberry will improve performance on complex tasks involving mobility and cognition.

02

Conditions studied

  • Aging
  • Age-related Cognitive Decline
  • Obesity

Keywords

  • Strawberry
  • Cognition
  • Gait
  • Posture
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 47 is below the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

USDA Human Nutrition Research Center on Aging is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • Cigarette smoking, use of nicotine replacement products, or smoking of marijuana/consumption of edibles in past 3 months or during the course of the study
  • History of stomach or bowel resection (other than appendectomy), gastric bypass or other bariatric weight loss procedure
  • Cancer of any type (except for non-melanoma skin) in past 3 yrs or actively using cancer chemotherapeutic agents
  • Clotting/bleeding disorders or ongoing anticoagulant use
  • Bilateral mastectomy with nodal dissection
  • No social security number (unable to pay stipend)
  • Blood biochemistries outside of normal range
  • Prior participation in a study involving berry supplementation at our institution
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
47 participants (actual)

Study arms

  • Experimental
    Strawberry

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

    Dietary Supplement: Strawberry

  • Placebo comparator
    Placebo

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

    Other: Placebo

Interventions

  • Dietary supplementStrawberry

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

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. Spatial Cognition

    Spatial cognition will be measured using a virtual navigation task.

    Time frame: Change from baseline at 90 days

Secondary outcomes

  1. Gait Speed

    Preferred gait speed will be measured using an instrumented treadmill.

    Time frame: Change from baseline at 90 days

07

Study locations

1 site
  • Tammy M Scott
    Boston, Massachusetts 02111, United States
08

References and documents

Publications

  • 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. PubMed 22264107 ↗
  • 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. PubMed 10479711 ↗
  • Miller 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. PubMed 28011241 ↗
  • Shukitt-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. PubMed 26392037 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03162913
Lead sponsor
USDA Human Nutrition Research Center on Aging
Collaborators
California Strawberry Commission
Responsible party
Barbara Shukitt-Hale (Research Psychologist, USDA Human Nutrition Research Center on Aging) — Principal investigator
First posted
May 22, 2017
Start date
Oct 1, 2017
Primary completion
Oct 20, 2023
Completion
Oct 20, 2023
Last update
Mar 28, 2024

Study contacts

Tammy M Scott, PhD
principal investigator · Tufts University
Barbara Shukitt-Hale, PhD
principal investigator · USDA Human Nutrition Research Center on Aging

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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