The Effects of Strawberry Supplementation on Memory and Gait Among Over-weight Older Adults
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ClinicalTrials.gov Identifier: NCT03162913 |
Recruitment Status :
Recruiting
First Posted : May 22, 2017
Last Update Posted : May 18, 2022
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Condition or disease | Intervention/treatment | Phase |
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Aging Age-related Cognitive Decline Obesity | Dietary Supplement: Strawberry Other: Placebo | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 49 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | The Effects of Strawberry Supplementation on Memory and Gait Among Over-weight Older Adults |
Actual Study Start Date : | October 1, 2017 |
Estimated Primary Completion Date : | October 1, 2022 |
Estimated Study Completion Date : | March 1, 2023 |

Arm | Intervention/treatment |
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Experimental: Strawberry
Participants randomized into this arm of the study consume freeze-dried strawberry powder.
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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.
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Other: Placebo
12g red, strawberry-flavored powder, twice daily with water, for 90 days |
- Spatial Cognition [ Time Frame: Change from baseline at 90 days ]Spatial cognition will be measured using a virtual navigation task.
- Gait Speed [ Time Frame: Change from baseline at 90 days ]Preferred gait speed will be measured using an instrumented treadmill.

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Ages Eligible for Study: | 55 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | 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:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03162913
Contact: Kimberly Dupiton | 617-556-3012 | Kimberly.Dupiton@tufts.edu |
United States, Massachusetts | |
Tammy M Scott | Recruiting |
Boston, Massachusetts, United States, 02111 | |
Contact: Tammy M Scott, PhD 617-556-3366 tammy.scott@tufts.edu | |
Principal Investigator: Tammy M Scott, PhD | |
Principal Investigator: Barbara Shukitt-Hale, PhD | |
Sub-Investigator: Marshall G Miller, PhD |
Principal Investigator: | Tammy M Scott, PhD | Tufts University | |
Principal Investigator: | Barbara Shukitt-Hale, PhD | USDA Human Nutrition Research Center on Aging |
Publications:
Responsible Party: | Barbara Shukitt-Hale, Research Psychologist, USDA Human Nutrition Research Center on Aging |
ClinicalTrials.gov Identifier: | NCT03162913 |
Other Study ID Numbers: |
12523 |
First Posted: | May 22, 2017 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Strawberry Cognition Gait Posture |
Overweight Cognitive Dysfunction Cognition Disorders |
Neurocognitive Disorders Mental Disorders Body Weight |