The Effect of Dietary Strawberry Supplementation on Older Adults

Aging Clinical Trial

Official title:

The Effect of Dietary Strawberry Supplementation on Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051140
• Other study ID #: ARS-2014-1
• Status: Completed
• Phase: N/A
• First received: January 29, 2014
• Last updated: September 1, 2015
• Start date: May 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: USDA Human Nutrition Research Center on Aging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This study is being conducted to assess the effect of dietary strawberry supplementation on cognition and mobility in older adults. It is hypothesized that plant compounds, present in strawberries, may improve cognition and mobility by protecting against oxidative stress and inflammation.

Description:

This study is being conducted to assess the effect of dietary strawberry supplementation vs. placebo on measures of cognition and mobility in older adults. Participants will visit the HNRCA on 4 occasions. During the first visit, participants will complete a dietary assessment and familiarize themselves with some of the cognitive tests used in the study. After a period of up to 45 days participants will return for the second visit. Participants will be randomized to consume either freeze dried strawberry powder or a placebo powder that tastes like strawberry. At visits 2, 3 and 4, participants will undergo tests of cognition, memory, gait and balance. In addition, blood samples and 24-hour urine will be collected at these visits. Tests include balance and gait assessment using a treadmill instrumented with pressure sensors which will measure postural sway and a variety of spatial/temporal gait parameters. Participants will also be affixed with surface electrodes to measure the activation of muscles in their legs during these balance and gait measurements. Participants will complete a battery of cognitive tests on paper and by computer. In the time between participants' visit 2 and visit 4, participants will receive a weekly telephone call to check in with them and remind them to continue taking the study powder. At the very end of the study, when all participants are finished, participants will receive a telephone call to debrief them and notify them which group they were randomized into. An optional tissue banking protocol will be offered for collection of additional blood to be banked at visits 2-4.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

Inclusion Criteria:

• Men and women are between the ages of 60 and 75 years

• Body mass index 18.5-29.9 kg/m2

• 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

• Absence of menstruation for a minimum of 12 months or surgical menopause.

Exclusion Criteria:

• Self-reported vegetarian or vegan.

• Any condition that has resulted in cognitive deficits, including but not limited to - Alzheimer's disease or other dementias, cerebrovascular accident, or head injury

• History of any neurologic disorder resulting in permanent or relapsing/remitting neurologic impairment including but not limited to Parkinson's disease, amyotrophic lateral sclerosis, Huntington's disease, peripheral neuropathy, or radiculopathy.

• History of any condition resulting in permanent muscle or mobility deficit that would interfere with walking independent of assistance for 20 minutes, including but not limited to amputation, fracture, arthritis, myopathy, or limb, hip or back surgery within the last year.

• Self-reported cognitive, memory, neurologic or functional deficits that are stated to interfere with activities of daily living or functional status.

• Any chronic condition associated with increased risk of falls such as vestibular disease, orthostatic hypotension or neuropathy.

• Falls within the last year, that occurred in the course or routine daily activities, which were not precipitated by unusual circumstances such as being pushed or falling on ice.

• Regular use (i.e. that cannot or should not be discontinued for the entire study period, as per the subject's personal physician) of medications or dietary supplements known or suspected to influence cognitive function, attention, ability to ambulate, gait, balance, or risk of falls that in the opinion of the study physician may influence study results or increase risk with participation in the study.

• Psychiatric disorders that could in the opinion of the study physician interfere with study testing, including bipolar disorder, psychosis, and major depression

• MMSE score of less than 24 at screening

• Gastrointestinal disorders that influence digestion and absorption of food

• Diabetes mellitus

• Liver dysfunction

• History of cirrhosis

• SGPT, SGOT, or total bilirubin > 2 x upper limit of normal

• Kidney disease as indicated by serum creatinine > 1.5 mg/dL at screening

• Cardiac or pulmonary conditions that limit ambulation or results in dyspnea with ambulation with walking required as part of activities of daily living.

• Reported allergy to strawberry or ingredients in the placebo.

• Ethanol use estimated to be on average > 2 servings/day of beer (12-ounces), wine (5 ounces) or liquor (1.5 ounces), or self-reported binge-drinking.

• Illicit drug use in the last 12 months.

• Cigarette smoking within the last 6 months or current use of nicotine.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-related Memory Disorders
• Aging
• Memory Disorders

Intervention

Dietary Supplement:
• Freeze-dried Strawberry
12g freeze-dried strawberry (powder), twice daily with water, for 90 days
• Strawberry Placebo
12g blue, strawberry-flavored powder, twice daily with water, for 90 days

Locations

Country	Name	City	State
United States	Jean Meyer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
USDA Human Nutrition Research Center on Aging	California Strawberry Commission

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Balance	sway velocity and sway area via pressure-sensor	Change from baseline at 45 days	No
Other	Balance	sway velocity and sway area via pressure-sensor	Change from baseline at 90 days	No
Primary	Cognition	Spatial memory and learning (virtual water maze); short-term memory (digit span), verbal learning and memory (California verbal learning Test), executive function (trail making test, task switching test), attention (attention network test)	Change from baseline at 45 days	No
Primary	Cognition	Spatial memory and learning (virtual water maze); short-term memory (digit span), verbal learning and memory (California verbal learning Test), executive function (trail making test, task switching test), attention (attention network test)	Change from baseline at 90 days	No
Secondary	Gait	gait speed, step length variability, step width variability via instrumented treadmill	Change from baseline at 45 days	No
Secondary	Gait	gait speed, step length variability, step width variability via instrumented treadmill	Change from baseline at 90 days	No

External Links

•   Agricultural Research Service (USDA)
•   California Strawberry Commission
•   Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University