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AgingNCT03162913

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

A study testing Strawberry in people with Aging and Age-related Cognitive Decline, run by USDA Human Nutrition Research Center on Aging at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 55 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Age-related Cognitive Decline, Obesity
What is being tested?
Strawberry
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
1 siteUnited States
Study dates
1 Oct 2017to 20 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tammy M Scott

    Boston, Massachusetts, 02111

Other trials in United States

About this study

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.

Being tested
Strawberry, Placebo
Keywords
Strawberry, Cognition, Gait, Posture
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • StrawberryDietary supplement

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

  • PlaceboOther

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

Study groups in NCT03162913
Study groupRoleWhat they receive
StrawberryExperimentalParticipants randomized into this arm of the study consume freeze-dried strawberry powder.
Receives: Dietary Supplement: Strawberry
PlaceboPlacebo comparatorParticipants randomized into this arm of the study consume a strawberry placebo powder.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Spatial Cognition

    Spatial cognition will be measured using a virtual navigation task.

    Measured: Change from baseline at 90 days

Secondary outcomes (1)

  1. Gait Speed

    Preferred gait speed will be measured using an instrumented treadmill.

    Measured: Change from baseline at 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2017
  2. Study start1 Oct 2017
  3. Primary completion20 Oct 2023
  4. Study completion20 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03162913
Sponsor's protocol ID
12523
Status last verified
Mar 2024
First submitted
19 May 2017
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Strawberry in people with Aging and Age-related Cognitive Decline, run by USDA Human Nutrition Research Center on Aging at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Spatial Cognition (time frame: Change from baseline at 90 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03162913, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

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