Mild Cognitive DeclineBERRYNCT01515098
Effect of Blueberries on Cognition and Body Composition in Elderly With Mild Cognitive Decline
A study testing Freeze-dried blueberries in people with Mild Cognitive Decline, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans. Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests… Read more about this study
- Who is it for?
- Ages 65 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Decline
- What is being tested?
- Freeze-dried blueberries
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Mar 2015
- 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 65 to 79 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women age 65 and older
- BMI between 18.5 and 34.5
- Close individual to report memory decline
Who cannot join
- History of central nervous system or psychiatric disorders
- Dementia or Alzheimer's diagnosis
- Diabetes
- Smoking >20 cigarettes/day
- Gastrointestinal/digestive disorders
- Uncontrolled chronic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutrition Research Institute
Kannapolis, North Carolina, 28081
About this study
Official title: The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline
Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans.
Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests, relative to those who consume a placebo.
Read more
Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an increase in processing speed and an improvement in memory abilities as measured in an electrophysiological paradigm and compared to those who consume a placebo.
Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition (fat mass vs. lean mass).
Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress and inflammatory markers.
- Conditions
- Mild Cognitive Decline
- Being tested
- Freeze-dried blueberries, Dextrose Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried blueberriesDietary supplement
Wild blueberries, freeze-dried and pulverized
Dextrose PlaceboDietary supplement
Placebo developed to closely match blueberry powder.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry Group | Experimental | 37 grams of dehydrated blueberries daily for 6 months Receives: Dietary Supplement: Freeze-dried blueberries |
| Placebo Group | Placebo comparator | 37 grams of dextrose powder daily for 6 months Receives: Dietary Supplement: Dextrose Placebo |
| Reference Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive test performance
Measured by CANTAB
Measured: Baseline, 180 days
Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)
Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP)
Measured: Baseline, 180 days
Secondary outcomes (2)
Change in body mass distribution
DXA scans to measure body composition at baseline and outcome will be compared for differences
Measured: Baseline, 180 days
Change in oxidative stress and inflammatory markers as measured in blood and urine
Oxidative stress and inflammatory markers will be measured in blood and compared between baseline and outcome.
Measured: Baseline, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carol Cheatham, PhD, University of North Carolina, Chapel Hill
- Investigators
- Carol L Cheatham, Ph.D., Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01515098
- Sponsor's protocol ID
- 11-2075
- Acronym
- BERRY
- Status last verified
- Mar 2022
- First submitted
- 18 Jan 2012
- Last updated
- 8 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheatham CL, Canipe LG 3rd, Millsap G, Stegall JM, Chai SC, Sheppard KW, Lila MA. Six-month intervention with wild blueberries improved speed of processing in mild cognitive decline: a double-blind, placebo-controlled, randomized clinical trial. Nutr Neurosci. 2023 Oct;26(10):1019-1033. doi: 10.1080/1028415X.2022.2117475. Epub 2022 Sep 6.
PubMed 36066009Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9.
PubMed 29523147
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blueberry Consumption on Cognition and Body Composition in Elderly Who Are Experiencing Mild Cognitive Decline
- ClinicalTrials.gov ID
- NCT01515098
- Acronym / sponsor ID
- BERRY / 11-2075
- Conditions
- Mild Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 23 Jan 2012 (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.
Purpose: The purpose of this study is to examine the effect of blueberry consumption on cognitive decline and body composition in humans.
Hypothesis 1: Adults with mild cognitive decline who consume blueberries will experience an improvement in cognitive abilities as measured by a standardized battery of tests, relative to those who consume a placebo.
Hypothesis 2: Adults with mild cognitive decline who consume blueberries will evidence an increase in processing speed and an improvement in memory abilities as measured in an electrophysiological paradigm and compared to those who consume a placebo.
Hypothesis 3: Daily intake of 35 g freeze-dried blueberries will improve body composition (fat mass vs. lean mass).
Hypothesis 4: Daily intake of 35 g freeze-dried blueberries will decrease oxidative stress and inflammatory markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blueberry Group | Experimental | Dietary Supplement: Freeze-dried blueberries37 grams of dehydrated blueberries daily for 6 months |
| Placebo Group | Placebo comparator | Dietary Supplement: Dextrose Placebo37 grams of dextrose powder daily for 6 months |
| Reference Group | No intervention | –No intervention |
Who may qualify
- Ages
- 65 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Men and women age 65 and older
- BMI between 18.5 and 34.5
- Close individual to report memory decline
Key exclusion criteria (6 listed)
- History of central nervous system or psychiatric disorders
- Dementia or Alzheimer's diagnosis
- Diabetes
- Smoking >20 cigarettes/day
- Gastrointestinal/digestive disorders
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 blueberriesWild blueberries, freeze-dried and pulverized | Dietary supplement | Blueberry Group |
| Dextrose PlaceboPlacebo developed to closely match blueberry powder. | Dietary supplement | Placebo Group |
Primary outcome
Change in cognitive test performance
Time frame: Baseline, 180 days
Measured by CANTAB
Change in brain activity (N200, P300) related to cognitive abilities as measured by event-related potentials (ERP)
Time frame: Baseline, 180 days
Recognition memory, speed of processing, and memory consolidation as measured by the electrophysiological technique known as event-related potentials (ERP)
2 secondary outcomes
Change in body mass distribution
Time frame: Baseline, 180 days
Change in oxidative stress and inflammatory markers as measured in blood and urine
Time frame: Baseline, 180 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 8 Mar 2022.
- Derived from this study: PubMed 36066009Cheatham CL, Canipe LG 3rd, Millsap G, Stegall JM, Chai SC, Sheppard KW, Lila MA. Six-month intervention with wild blueberries improved speed of processing in mild cognitive decline: a double-blind, placebo-controlled, randomized clinical trial. Nutr Neurosci. 2023 Oct;26(10):1019-1033. doi: 10.1080/1028415X.2022.2117475. Epub 2022 Sep 6.
- Derived from this study: PubMed 29523147Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9.
Related trials for Mild Cognitive Decline
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
Carol L Cheatham, Ph.D. principal investigator
University of North Carolina, Chapel Hill
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 blueberries in people with Mild Cognitive Decline, run by University of North Carolina, Chapel Hill 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 3 inclusion and 6 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 8 Mar 2022. 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?
Change in cognitive test performance (time frame: Baseline, 180 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 NCT01515098, which also lists 2 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 8 Mar 2022.