HealthyNCT03547102
Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults
A study testing Cherry concentrate in people with Healthy, run by University of Exeter.
Trial summary
Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain perfusion in healthy older adults Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cherry concentrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- 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
- physically inactive consuming 5 or less portions of fruit per day Addenbrookes cognitive examination III score >88
Who cannot join
- physically active consuming more than 5 portions of fruit per day Addenbrookes cognitive examination III score <88 Contraindications for MRI
About this study
Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain perfusion in healthy older adults
Read the detailed description
The investigators will perform a double blind, randomised controlled study to determine whether cherry polyphenols improve peripheral vascular function and cerebral perfusion resulting in improved task related brain activation and cognitive function. 30 healthy elderly men and women 60-85y years will be recruited to complete 8-week supplementation with MC concentrate or an isoenergetic cherry placebo concentrate. Participants will be pair matched for age, sex, and cognitive function (Adenbrooke's Cognitive Examination III, ACE-III) and then randomised using a sealed envelope system to receive either placebo or cherry.
- Conditions
- Healthy
- Being tested
- Cherry concentrate, Placebo concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cherry concentrateDietary supplement
Placebo concentrateDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Cherry concentrate | Active comparator | 8 weeks supplementation with montmorency cherry concentrate Receives: Dietary Supplement: Cherry concentrate |
| Placebo concentrate | Placebo comparator | 8 weeks supplementation with placebo isoenergetic cherry concentrate Receives: Dietary Supplement: Placebo concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain perfusion
Arterial spin labelling using MRI, measure will be reported as ml/min
Measured: Change from baseline to 8 weeks supplementation
Secondary outcomes (3)
Cognitive function
Battery of cognitive function tasks assessing executive function, global cognitive function score will be reported
Measured: Change from baseline to 8 weeks supplementation
Brain activation (fMRI)
fMRI using a hippocampal biased task
Measured: Change from baseline to 8 weeks supplementation
Plasma nitrite concentration
Plasma sample analysed via chemiluminescence technique
Measured: Change from baseline to 8 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study startJan 2016
- Primary completionMay 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joanna L Bowtell, PhD, Principal investigator, University of Exeter
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547102
- Sponsor's protocol ID
- 115229/02
- Status last verified
- Jun 2018
- First submitted
- 2 Dec 2016
- Last updated
- 26 Jun 2018
- 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 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT03547102
- Acronym / sponsor ID
- 115229/02
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Jun 2018 (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.
Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain perfusion in healthy older adults
Detailed description
The investigators will perform a double blind, randomised controlled study to determine whether cherry polyphenols improve peripheral vascular function and cerebral perfusion resulting in improved task related brain activation and cognitive function. 30 healthy elderly men and women 60-85y years will be recruited to complete 8-week supplementation with MC concentrate or an isoenergetic cherry placebo concentrate. Participants will be pair matched for age, sex, and cognitive function (Adenbrooke's Cognitive Examination III, ACE-III) and then randomised using a sealed envelope system to receive either placebo or cherry.
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 |
|---|---|---|
| Cherry concentrate | Active comparator | Dietary Supplement: Cherry concentrate8 weeks supplementation with montmorency cherry concentrate |
| Placebo concentrate | Placebo comparator | Dietary Supplement: Placebo concentrate8 weeks supplementation with placebo isoenergetic cherry concentrate |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- physically inactive consuming 5 or less portions of fruit per day Addenbrookes cognitive examination III score >88
Key exclusion criteria (1 listed)
- physically active consuming more than 5 portions of fruit per day Addenbrookes cognitive examination III score <88 Contraindications for MRI
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 |
|---|---|---|
| Cherry concentrate | Dietary supplement | Cherry concentrate |
| Placebo concentrate | Dietary supplement | Placebo concentrate |
Primary outcome
Brain perfusion
Time frame: Change from baseline to 8 weeks supplementation
Arterial spin labelling using MRI, measure will be reported as ml/min
3 secondary outcomes
Cognitive function
Time frame: Change from baseline to 8 weeks supplementation
Brain activation (fMRI)
Time frame: Change from baseline to 8 weeks supplementation
Plasma nitrite concentration
Time frame: Change from baseline to 8 weeks 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 26 Jun 2018.
- 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 L Bowtell, PhD principal investigator
University of Exeter
Questions about this trial
What is this clinical trial studying?
A study testing Cherry concentrate in people with Healthy, 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 1 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 26 Jun 2018. 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 8 weeks 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 26 Jun 2018.