Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults
June 21, 2018 updated by: University of Exeter
Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain perfusion in healthy older adults
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- physically inactive consuming 5 or less portions of fruit per day Addenbrookes cognitive examination III score >88
Exclusion Criteria:
- physically active consuming more than 5 portions of fruit per day Addenbrookes cognitive examination III score <88 Contraindications for MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Cherry concentrate
8 weeks supplementation with montmorency cherry concentrate
|
|
|
PLACEBO_COMPARATOR: Placebo concentrate
8 weeks supplementation with placebo isoenergetic cherry concentrate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Brain perfusion
Time Frame: Change from baseline to 8 weeks supplementation
|
Arterial spin labelling using MRI, measure will be reported as ml/min
|
Change from baseline to 8 weeks supplementation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: Change from baseline to 8 weeks supplementation
|
Battery of cognitive function tasks assessing executive function, global cognitive function score will be reported
|
Change from baseline to 8 weeks supplementation
|
|
Brain activation (fMRI)
Time Frame: Change from baseline to 8 weeks supplementation
|
fMRI using a hippocampal biased task
|
Change from baseline to 8 weeks supplementation
|
|
Plasma nitrite concentration
Time Frame: Change from baseline to 8 weeks supplementation
|
Plasma sample analysed via chemiluminescence technique
|
Change from baseline to 8 weeks supplementation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joanna L Bowtell, PhD, University of Exeter
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (ACTUAL)
May 1, 2016
Study Completion (ACTUAL)
December 1, 2016
Study Registration Dates
First Submitted
December 2, 2016
First Submitted That Met QC Criteria
May 23, 2018
First Posted (ACTUAL)
June 6, 2018
Study Record Updates
Last Update Posted (ACTUAL)
June 26, 2018
Last Update Submitted That Met QC Criteria
June 21, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 115229/02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.