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

Primary Purpose

Aging, Age-related Cognitive Decline, Obesity

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Strawberry
Placebo
Sponsored by
USDA Human Nutrition Research Center on Aging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Strawberry, Cognition, Gait, Posture

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Tammy M ScottRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Strawberry

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Spatial Cognition
Spatial cognition will be measured using a virtual navigation task.

Secondary Outcome Measures

Gait Speed
Preferred gait speed will be measured using an instrumented treadmill.

Full Information

First Posted
May 19, 2017
Last Updated
May 9, 2023
Sponsor
USDA Human Nutrition Research Center on Aging
Collaborators
California Strawberry Commission
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1. Study Identification

Unique Protocol Identification Number
NCT03162913
Brief Title
The Effects of Strawberry Supplementation on Memory and Gait Among Over-weight Older Adults
Official Title
The Effects of Strawberry Supplementation on Memory and Gait Among Over-weight Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
USDA Human Nutrition Research Center on Aging
Collaborators
California Strawberry Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Age-related Cognitive Decline, Obesity
Keywords
Strawberry, Cognition, Gait, Posture

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Strawberry
Arm Type
Experimental
Arm Description
Participants randomized into this arm of the study consume freeze-dried strawberry powder.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants randomized into this arm of the study consume a strawberry placebo powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Strawberry
Intervention Description
12g freeze-dried strawberry (powder), twice daily with water, for 90 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
12g red, strawberry-flavored powder, twice daily with water, for 90 days
Primary Outcome Measure Information:
Title
Spatial Cognition
Description
Spatial cognition will be measured using a virtual navigation task.
Time Frame
Change from baseline at 90 days
Secondary Outcome Measure Information:
Title
Gait Speed
Description
Preferred gait speed will be measured using an instrumented treadmill.
Time Frame
Change from baseline at 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kimberly Dupiton
Phone
617-556-3012
Email
Kimberly.Dupiton@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy M Scott, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Shukitt-Hale, PhD
Organizational Affiliation
USDA Human Nutrition Research Center on Aging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tammy M Scott
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy M Scott, PhD
Phone
617-556-3366
Email
tammy.scott@tufts.edu
First Name & Middle Initial & Last Name & Degree
Tammy M Scott, PhD
First Name & Middle Initial & Last Name & Degree
Barbara Shukitt-Hale, PhD
First Name & Middle Initial & Last Name & Degree
Marshall G Miller, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22264107
Citation
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.
Results Reference
background
PubMed Identifier
10479711
Citation
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.
Results Reference
background
PubMed Identifier
28011241
Citation
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.
Results Reference
background
PubMed Identifier
26392037
Citation
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.
Results Reference
background
Links:
URL
http://hnrca.tufts.edu/
Description
USDA Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
URL
http://www.ars.usda.gov/main/main.htm
Description
Agricultural Research Service (USDA)
URL
http://www.calstrawberry.com/
Description
California Strawberry Commission

Learn more about this trial

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

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