Brain AgingNCT05024916
Blueberry Intervention Study for Brain Aging
A study testing Intervention in people with Brain Aging, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if increased blueberry intake helps increase brain antioxidant (glutathione) and cerebral blood flow in older adults. Read more about this study
- Who is it for?
- Ages 65 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Aging
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2022to 3 Oct 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 89 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Speak English as the primary language and be able to read and write.
- Good general health with no concomitant diseases
- Low berry consumption (≤1 serving/week)
- Cognitively normal (Mini-Mental State Exam Score ≥24)
- BMI range=18.5-35 kg/m2.
Who cannot join
- Presence of any central neurological diseases or prior major head trauma with loss of consciousness
- Presence of an active unstable and life-threatening systemic illness
- Presence of major psychiatric disorders within the past 3 years including depression, anxiety, and alcohol or drug abuse
- Presence of diabetes mellitus; metabolic syndrome or uncontrolled hypertension
- Use of psychoactive and investigational medications
- MRI contraindications (pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia)
- Blueberry or salicylate allergy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: The Effect of Blueberry Consumption on Brain Health in Older Adults: in Vivo Measures of Cerebral Antioxidant and Cerebral Blood Flow
The purpose of this study is to determine if increased blueberry intake helps increase brain antioxidant (glutathione) and cerebral blood flow in older adults.
Read the detailed description
Consuming blueberries may improve brain health of older adults by increasing the antioxidant levels in the brain to protect nerve cells in the aging brain. Researchers think that there may be a relationship between the brain's antioxidant defense system and blueberry intake due to the high antioxidant content in blueberries.
This study will investigate if blueberry intake may aid in enhancing glutathione levels and cerebral blood flow using special Magnetic Resonance Imaging (MRI) scans.
Participants will be asked to make a total of up to 4 visits to the research site. Participation will last about 3 months.
- Conditions
- Brain Aging
- Being tested
- Intervention, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionDietary supplement
Also called Freeze-dried blueberries
26 g packets of freeze-dried blueberries (equivalent to 1 cup of fresh blueberries) will be given to participants to be consumed daily. Participants will be asked to consume 1 packet per day for 3 months.
ControlDietary supplement
Also called Placebo
26 g packets of isocaloric carbohydrate-matched powder will be given to participants to be consumed daily. Participants will be asked to consume 1 packet/day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants will receive the dietary intervention. Participants will take 1 serving of blueberries/day. Receives: Dietary Supplement: Intervention |
| Control | Active comparator | Participants will receive a placebo. Participants will take 1 serving of placebo/day. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in brain glutathione (GSH) levels
Measure of brain GSH with a 3 T MRI scanner
Measured: Change from baseline to 3 months
Change in cerebral blood flow (CBF)
Measure of CBF with a 3 T MRI scanner
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Jun 2022
- Primary completion3 Oct 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Principal investigator, In-Young Choi, Ph.D., University of Kansas Medical Center
- Investigators
- In-Young Choi, PhD, Principal investigator, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024916
- Sponsor's protocol ID
- STUDY00147614
- Status last verified
- May 2025
- First submitted
- 23 Aug 2021
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blueberry Consumption on Brain Health in Older Adults: in Vivo Measures of Cerebral Antioxidant and Cerebral Blood Flow
- ClinicalTrials.gov ID
- NCT05024916
- Acronym / sponsor ID
- STUDY00147614
- Conditions
- Brain Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 3 Oct 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 27 Aug 2021 (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.
The purpose of this study is to determine if increased blueberry intake helps increase brain antioxidant (glutathione) and cerebral blood flow in older adults.
Detailed description
Consuming blueberries may improve brain health of older adults by increasing the antioxidant levels in the brain to protect nerve cells in the aging brain. Researchers think that there may be a relationship between the brain's antioxidant defense system and blueberry intake due to the high antioxidant content in blueberries.
This study will investigate if blueberry intake may aid in enhancing glutathione levels and cerebral blood flow using special Magnetic Resonance Imaging (MRI) scans.
Participants will be asked to make a total of up to 4 visits to the research site. Participation will last about 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: InterventionParticipants will receive the dietary intervention. Participants will take 1 serving of blueberries/day. |
| Control | Active comparator | Dietary Supplement: ControlParticipants will receive a placebo. Participants will take 1 serving of placebo/day. |
Who may qualify
- Ages
- 65 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Speak English as the primary language and be able to read and write.
- Good general health with no concomitant diseases
- Low berry consumption (≤1 serving/week)
- Cognitively normal (Mini-Mental State Exam Score ≥24)
- BMI range=18.5-35 kg/m2.
Key exclusion criteria (8 listed)
- Presence of any central neurological diseases or prior major head trauma with loss of consciousness
- Presence of an active unstable and life-threatening systemic illness
- Presence of major psychiatric disorders within the past 3 years including depression, anxiety, and alcohol or drug abuse
- Presence of diabetes mellitus; metabolic syndrome or uncontrolled hypertension
- Use of psychoactive and investigational medications
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 |
|---|---|---|
| InterventionAlso: Freeze-dried blueberries26 g packets of freeze-dried blueberries (equivalent to 1 cup of fresh blueberries) will be given to participants to be consumed daily. Participants will be asked to consume 1 packet per day for 3 months. | Dietary supplement | Intervention |
| ControlAlso: Placebo26 g packets of isocaloric carbohydrate-matched powder will be given to participants to be consumed daily. Participants will be asked to consume 1 packet/day for 3 months. | Dietary supplement | Control |
Primary outcome
Change in brain glutathione (GSH) levels
Time frame: Change from baseline to 3 months
Measure of brain GSH with a 3 T MRI scanner
Change in cerebral blood flow (CBF)
Time frame: Change from baseline to 3 months
Measure of CBF with a 3 T MRI scanner
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 21 May 2025.
- 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.
In-Young Choi, PhD principal investigator
Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Brain Aging, run by University of Kansas Medical Center 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 5 inclusion and 8 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 21 May 2025. 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. 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 brain glutathione (GSH) levels (time frame: Change from baseline to 3 months). 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?
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 21 May 2025.