NCT03547102

Brief Summary

Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain perfusion in healthy older adults

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

4 months

First QC Date

December 2, 2016

Last Update Submit

June 21, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Brain perfusion

    Arterial spin labelling using MRI, measure will be reported as ml/min

    Change from baseline to 8 weeks supplementation

Secondary Outcomes (3)

  • Cognitive function

    Change from baseline to 8 weeks supplementation

  • Brain activation (fMRI)

    Change from baseline to 8 weeks supplementation

  • Plasma nitrite concentration

    Change from baseline to 8 weeks supplementation

Study Arms (2)

Cherry concentrate

ACTIVE COMPARATOR

8 weeks supplementation with montmorency cherry concentrate

Dietary Supplement: Cherry concentrate

Placebo concentrate

PLACEBO COMPARATOR

8 weeks supplementation with placebo isoenergetic cherry concentrate

Dietary Supplement: Placebo concentrate

Interventions

Cherry concentrateDIETARY_SUPPLEMENT
Cherry concentrate
Placebo concentrateDIETARY_SUPPLEMENT
Placebo concentrate

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • physically inactive consuming 5 or less portions of fruit per day Addenbrookes cognitive examination III score \>88

You may not qualify if:

  • physically active consuming more than 5 portions of fruit per day Addenbrookes cognitive examination III score \<88 Contraindications for MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Joanna L Bowtell, PhD

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

June 6, 2018

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

December 1, 2016

Last Updated

June 26, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share