Cognitive DeclineNCT05764824
Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults
A study testing Blueberry powder in people with Cognitive Decline and Nutrition, Healthy, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults. Read more about this study
- Who is it for?
- Ages 65 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Nutrition, Healthy, Brain Injuries
- What is being tested?
- Blueberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2023to 11 Sep 2024
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Adults aged 65-99 years
- Able to travel to Brigham and Women's Hospital for 4 clinic visits
Who cannot join
- Known allergies to blueberries
- Unable to abstain from blueberry consumption during the study period
- Inability to provide informed consent
- Planned major surgery during study period or recent major surgery up to 3 months before recruitment
- Organ transplant
- Plan to move out of greater Boston area during the study period
- Diagnosis of dementia, severe cognitive decline, end-stage renal disease, substance abuse, insulin-dependent diabetes mellitus, major cancer excluding non-melanoma skin cancer, and schizophrenia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults: a Randomized Placebo-controlled Trial
This study will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.
Read the detailed description
In a randomized, double-blind placebo, controlled design, the investigators will test the effects of 20 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.
- Conditions
- Cognitive Decline, Nutrition, Healthy, Brain Injuries
- Being tested
- Blueberry powder, Controlled and matched powder
- Medical subject headings
- Cognitive Dysfunction, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry powderDietary supplement
20 g per day of blueberry powder
Controlled and matched powderOther
20 g per day
| Study group | Role | What they receive |
|---|---|---|
| Blueberry group | Active comparator | Blueberry arm Receives: Dietary Supplement: Blueberry powder |
| Control group | Placebo comparator | Control arm Receives: Other: Controlled and matched powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks
Change will be calculated as difference between plasma NFL concentration measured at 24 weeks and NFL concentration measured at baseline.
Measured: Baseline and at 24 weeks after the intervention
Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks
Change will be calculated as difference between plasma pTau-181 concentration measured at 24 weeks and plasma concentration of pTau-181 measured at baseline
Measured: Baseline and at 24 weeks post intervention
Secondary outcomes (3)
Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks
Change will be calculated as difference between plasma concentration of GFAB measured at 24 weeks and plasma GFAB concentration measured at baseline
Measured: Baseline and at 24 weeks post intervention
Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks
Change will be computed as difference between serum concentration of NEFA measured at 24 weeks and serum NEFA concentration measured at baseline
Measured: Baseline and 24 weeks post intervention
Change in cognitive battery test score between baseline and 24 weeks post intervention
The investigators will use CANTAB (computer-based and interactive software) to complete 8 cognitive battery tests including a) Motor screening task; b) Reaction time; c) Paired associates learning; d) Spatial working memory; e) Pattern recognition memory; f) Delayed matching to sample; g) Rapid visual information processing; and h) Match to sample visual search. The computer automatically calculates a composite score from these 8 tests (a-h) and the investigators will define change in cognitive battery test score as difference in composite score between 24 weeks and baseline.
Measured: Baseline and at 24 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start1 Oct 2023
- Primary completion11 Sep 2024
- Study completion11 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Djousse, MD, ScD, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764824
- Sponsor's protocol ID
- 2022P002554
- Status last verified
- Aug 2026
- First submitted
- 31 Jan 2023
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guardino ET, Gabriel O, Mukamal KJ, Djousse L. Effects of a 24-week intervention with freeze-dried blueberries on brain health in older adults: A randomized double-blind, placebo-controlled trial. Clin Nutr ESPEN. 2026 Aug;74:103377. doi: 10.1016/j.clnesp.2026.103377. Epub 2026 Jun 6.
PubMed 42251891
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Effects of Blueberry Supplementation on Brain Health in Older Adults: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05764824
- Acronym / sponsor ID
- 2022P002554
- Conditions
- Cognitive Decline, Nutrition, Healthy, Brain Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 11 Sep 2024 (actual)
- Study completion
- 11 Sep 2024 (actual)
- First posted
- 13 Mar 2023 (actual)
- 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 will test whether consuming blueberry powder 20g/d for 24 weeks can improve memory and other cognitive function and alter serum biomarkers of brain injury among older adults.
Detailed description
In a randomized, double-blind placebo, controlled design, the investigators will test the effects of 20 g/d of blueberry powder for 24 weeks on cognitive function and serum biomarkers of brain injury among older adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry group | Active comparator | Dietary Supplement: Blueberry powderBlueberry arm |
| Control group | Placebo comparator | Other: Controlled and matched powderControl arm |
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Adults aged 65-99 years
- Able to travel to Brigham and Women's Hospital for 4 clinic visits
Key exclusion criteria (7 listed)
- Known allergies to blueberries
- Unable to abstain from blueberry consumption during the study period
- Inability to provide informed consent
- Planned major surgery during study period or recent major surgery up to 3 months before recruitment
- Organ transplant
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 |
|---|---|---|
| Blueberry powder20 g per day of blueberry powder | Dietary supplement | Blueberry group |
| Controlled and matched powder20 g per day | Other | Control group |
Primary outcome
Change in plasma concentration of neurofilament light (NFL) between baseline and 24 weeks
Time frame: Baseline and at 24 weeks after the intervention
Change will be calculated as difference between plasma NFL concentration measured at 24 weeks and NFL concentration measured at baseline.
Change in plasma concentration of phosphorylated tau (pTau-181) between baseline and 24 weeks
Time frame: Baseline and at 24 weeks post intervention
Change will be calculated as difference between plasma pTau-181 concentration measured at 24 weeks and plasma concentration of pTau-181 measured at baseline
3 secondary outcomes
Change in plasma concentration of glial fibrillary acid protein (GFAB) between baseline and 24 weeks
Time frame: Baseline and at 24 weeks post intervention
Change in concentration of serum non-esterified fatty acids (NEFA) between baseline and 24 weeks
Time frame: Baseline and 24 weeks post intervention
Change in cognitive battery test score between baseline and 24 weeks post intervention
Time frame: Baseline and at 24 weeks post intervention
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 13 Aug 2026.
- Results publication: PubMed 42251891Guardino ET, Gabriel O, Mukamal KJ, Djousse L. Effects of a 24-week intervention with freeze-dried blueberries on brain health in older adults: A randomized double-blind, placebo-controlled trial. Clin Nutr ESPEN. 2026 Aug;74:103377. doi: 10.1016/j.clnesp.2026.103377. Epub 2026 Jun 6.
- Link to manuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry powder in people with Cognitive Decline and Nutrition, Healthy, run by Brigham and Women's Hospital 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 2 inclusion and 7 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 13 Aug 2026. 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 plasma concentration of neurofilament light (NFL) between baseline and 24 weeks (time frame: Baseline and at 24 weeks after the intervention). 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 NCT05764824, which also lists 1 linked publication.
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 13 Aug 2026.