AgingNCT01888848
Effects of Blueberry on Cognition and Mobility in Older Adults
A study testing Freeze-dried Blueberry in people with Aging and Age-Related Memory Disorders, run by USDA Human Nutrition Research Center on Aging at 1 site in United States.
Trial summary
This study is being conducted to assess the effect of dietary blueberry supplementation on cognition and mobility in older adults. It is hypothesized that plant compounds, present in blueberries, may improve cognition and mobility by protecting against oxidative stress and inflammation. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Age-Related Memory Disorders
- What is being tested?
- Freeze-dried Blueberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Feb 2014
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 blueberry 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Meyer USDA Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: Effects of Dietary Blueberry Supplementation on Cognition and Mobility in Healthy Older Adults
This study is being conducted to assess the effect of dietary blueberry supplementation on cognition and mobility in older adults. It is hypothesized that plant compounds, present in blueberries, may improve cognition and mobility by protecting against oxidative stress and inflammation.
Read the detailed description
This study is being conducted to assess the effect of dietary blueberry 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 blueberry powder or a placebo powder that tastes like blueberry. 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.
- Conditions
- Aging, Age-Related Memory Disorders
- Being tested
- Freeze-dried Blueberry, Blueberry Placebo
- Keywords
- Postural Balance, Walking, Gait, Cognition, Learning, Memory, Blueberry, Antioxidants, Anti-Inflammatory Agents, Brain
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried BlueberryDietary supplement
12g freeze-dried blueberry (powder), twice daily with water, for 90 days
Blueberry PlaceboDietary supplement
12g blue, blueberry-flavored powder, twice daily with water, for 90 days
| Study group | Role | What they receive |
|---|---|---|
| blueberry | Experimental | Participants randomized into this arm of the study consume freeze-dried blueberry. Receives: Dietary Supplement: Freeze-dried Blueberry |
| placebo | Placebo comparator | Participants randomized into this arm of the study consume a blueberry placebo. Receives: Dietary Supplement: Blueberry Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognition
Spatial memory and learning (Morris 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)
Measured: change from baseline at 45 days
cognition
Spatial memory and learning (Morris 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)
Measured: Change from baseline at 90 days
Secondary outcomes (2)
Gait
gait speed, step length variability, step width variability via instrumented treadmill
Measured: Change from baseline at 90 days
Gait
gait speed, step length variability, step width variability via instrumented treadmill
Measured: Change from baseline at 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJan 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Human Nutrition Research Center on Aging
- Sponsor type
- US federal agency
- Collaborators
- U.S. Highbush Blueberry Council, Tufts University
- Responsible party
- Principal investigator, Barbara Shukitt-Hale, USDA Human Nutrition Research Center on Aging
- Investigators
- Edward Saltzman, MD, Principal investigator, Tufts UniversityBarbara Shukitt-Hale, PhD, Study director, United States Department of Agriculture (USDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01888848
- Sponsor's protocol ID
- USDAHNRC-2013-1
- Other IDs
- 1950-51000-070-19R
- Status last verified
- May 2015
- First submitted
- 13 Jun 2013
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- 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 22264107Joseph 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 10479711Krikorian R, Shidler MD, Nash TA, Kalt W, Vinqvist-Tymchuk MR, Shukitt-Hale B, Joseph JA. Blueberry supplementation improves memory in older adults. J Agric Food Chem. 2010 Apr 14;58(7):3996-4000. doi: 10.1021/jf9029332.
PubMed 20047325
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Blueberry Supplementation on Cognition and Mobility in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT01888848
- Acronym / sponsor ID
- USDAHNRC-2013-1
- Conditions
- Aging, Age-Related Memory Disorders
- Keywords
- Postural Balance, Walking, Gait, Cognition, Learning, Memory, Blueberry, Antioxidants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- USDA Human Nutrition Research Center on AgingUS federal agency
- Collaborators
- U.S. Highbush Blueberry Council, Tufts University
- Study start
- Jan 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to assess the effect of dietary blueberry supplementation on cognition and mobility in older adults. It is hypothesized that plant compounds, present in blueberries, may improve cognition and mobility by protecting against oxidative stress and inflammation.
Detailed description
This study is being conducted to assess the effect of dietary blueberry 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 blueberry powder or a placebo powder that tastes like blueberry. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| blueberry | Experimental | Dietary Supplement: Freeze-dried BlueberryParticipants randomized into this arm of the study consume freeze-dried blueberry. |
| placebo | Placebo comparator | Dietary Supplement: Blueberry PlaceboParticipants randomized into this arm of the study consume a blueberry placebo. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freeze-dried Blueberry12g freeze-dried blueberry (powder), twice daily with water, for 90 days | Dietary supplement | blueberry |
| Blueberry Placebo12g blue, blueberry-flavored powder, twice daily with water, for 90 days | Dietary supplement | placebo |
Primary outcome
cognition
Time frame: change from baseline at 45 days
Spatial memory and learning (Morris 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)
cognition
Time frame: Change from baseline at 90 days
Spatial memory and learning (Morris 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)
2 secondary outcomes
Gait
Time frame: Change from baseline at 90 days
Gait
Time frame: Change from baseline at 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Background: PubMed 22264107Miller 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.
- Background: PubMed 10479711Joseph 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.
- Background: PubMed 20047325Krikorian R, Shidler MD, Nash TA, Kalt W, Vinqvist-Tymchuk MR, Shukitt-Hale B, Joseph JA. Blueberry supplementation improves memory in older adults. J Agric Food Chem. 2010 Apr 14;58(7):3996-4000. doi: 10.1021/jf9029332.
- Human Nutrition Research Center on Aging at Tufts University websiteLink provided by the sponsor.
- USDA ARS websiteLink provided by the sponsor.
- US Highbush Blueberry Council websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Saltzman, MD principal investigator
Tufts University
Barbara Shukitt-Hale, PhD study director
United States Department of Agriculture (USDA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freeze-dried Blueberry in people with Aging and Age-Related Memory Disorders, 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 6 inclusion and 21 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 27 May 2015. 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?
cognition (time frame: change from baseline at 45 days). The study lists 2 primary outcomes in all. 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 NCT01888848, which also lists 3 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 27 May 2015.