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

March 27, 2024 updated by: Barbara Shukitt-Hale, USDA Human Nutrition Research Center on Aging
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tammy M Scott

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strawberry
Participants randomized into this arm of the study consume freeze-dried strawberry powder.
Dietary supplement: Strawberry
12g freeze-dried strawberry (powder), twice daily with water, for 90 days
Placebo Comparator: Placebo
Participants randomized into this arm of the study consume a strawberry placebo powder.
Other: Placebo
12g red, strawberry-flavored powder, twice daily with water, for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spatial Cognition
Time Frame: Change from baseline at 90 days
Spatial cognition will be measured using a virtual navigation task.
Change from baseline at 90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Speed
Time Frame: Change from baseline at 90 days
Preferred gait speed will be measured using an instrumented treadmill.
Change from baseline at 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Human Nutrition Research Center on Aging

Collaborators

California Strawberry Commission

Investigators

  • Principal Investigator: Tammy M Scott, PhD, Tufts University
  • Principal Investigator: Barbara Shukitt-Hale, PhD, USDA Human Nutrition Research Center on Aging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Actual)

October 20, 2023

Study Completion (Actual)

October 20, 2023

Study Registration Dates

First Submitted

May 19, 2017

First Submitted That Met QC Criteria

May 19, 2017

First Posted (Actual)

May 22, 2017

Study Record Updates

Last Update Posted (Actual)

March 28, 2024

Last Update Submitted That Met QC Criteria

March 27, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12523

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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