Cognitive AgingNCT02985580
Effects of Blueberry Juice Consumption on Cognitive Function in Healthy Older People
A study testing Blueberry in people with Cognitive Aging, run by University of Exeter.
Trial summary
Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties, which in rodent models are neuro-protective. The risk of developing dementia is reduced in people habitually consuming high flavonoid intakes, but data from human intervention studies is sparse. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Aging
- What is being tested?
- Blueberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Sep 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 60-80y
- Addenbrooke's Cognitive Examination III questionnaire > 88
- Consuming 5 or less portions of fruit per day
Who cannot join
- Addenbrooke's Cognitive Examination III questionnaire < 88 Contraindications for MRI Consuming more than 5 portions of fruit per day
About this study
Official title: Effects of Blueberry Juice Consumption on Brain Activation and Perfusion in Healthy Older People
Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties, which in rodent models are neuro-protective. The risk of developing dementia is reduced in people habitually consuming high flavonoid intakes, but data from human intervention studies is sparse. We therefore investigated whether 12 weeks of blueberry concentrate supplementation improved cognitive function in healthy elderly via increased brain activation and perfusion.
- Conditions
- Cognitive Aging
- Being tested
- Blueberry, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueberryDietary supplement
PlaceboDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Blueberry | Active comparator | Blueberry concentrate consumed daily for 12 weeks. Receives: Dietary Supplement: Blueberry |
| Placebo | Placebo comparator | Placebo concentrate consumed daily for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain perfusion
MRI - arterial spin labelling
Measured: Change from baseline to 12 weeks dietary supplementation
Secondary outcomes (5)
Brain activation
fMRI whilst performing modified Stroop task
Measured: Change from baseline to 12 weeks dietary supplementation
Cognitive function tests
Cogstate battery of tests
Measured: Change from baseline to 12 weeks dietary supplementation
Blood biomarkers of inflammation
CRP, IL6,
Measured: Change from baseline to 12 weeks dietary supplementation
Blood biomarkers of oxidative stress
protein carbonyls, glutathione
Measured: Change from baseline to 12 weeks dietary supplementation
Blood biomarkers of neurogenesis
BDNF
Measured: Change from baseline to 12 weeks dietary supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startOct 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna Bowtell, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985580
- Sponsor's protocol ID
- 1314/134617
- Status last verified
- Sep 2016
- First submitted
- 13 Sep 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blueberry Juice Consumption on Brain Activation and Perfusion in Healthy Older People
- ClinicalTrials.gov ID
- NCT02985580
- Acronym / sponsor ID
- 1314/134617
- Conditions
- Cognitive Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 7 Dec 2016 (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.
Blueberries are rich in flavonoids that possess antioxidant and anti-inflammatory properties, which in rodent models are neuro-protective. The risk of developing dementia is reduced in people habitually consuming high flavonoid intakes, but data from human intervention studies is sparse. We therefore investigated whether 12 weeks of blueberry concentrate supplementation improved cognitive function in healthy elderly via increased brain activation and perfusion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry | Active comparator | Dietary Supplement: BlueberryBlueberry concentrate consumed daily for 12 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo concentrate consumed daily for 12 weeks. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 60-80y
- Addenbrooke's Cognitive Examination III questionnaire > 88
- Consuming 5 or less portions of fruit per day
Key exclusion criteria (1 listed)
- Addenbrooke's Cognitive Examination III questionnaire < 88 Contraindications for MRI Consuming more than 5 portions of fruit per day
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 | Dietary supplement | Blueberry |
| Placebo | Dietary supplement | Placebo |
Primary outcome
Brain perfusion
Time frame: Change from baseline to 12 weeks dietary supplementation
MRI - arterial spin labelling
5 secondary outcomes
Brain activation
Time frame: Change from baseline to 12 weeks dietary supplementation
Cognitive function tests
Time frame: Change from baseline to 12 weeks dietary supplementation
Blood biomarkers of inflammation
Time frame: Change from baseline to 12 weeks dietary supplementation
Blood biomarkers of oxidative stress
Time frame: Change from baseline to 12 weeks dietary supplementation
Blood biomarkers of neurogenesis
Time frame: Change from baseline to 12 weeks dietary supplementation
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 7 Dec 2016.
- 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.
Joanna Bowtell, PhD principal investigator
University of Exeter
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry in people with Cognitive Aging, run by University of Exeter.
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 1 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Brain perfusion (time frame: Change from baseline to 12 weeks dietary supplementation). 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 7 Dec 2016.