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

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.

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.

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