Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT03547102
Status:
COMPLETED
Last Update Posted:
2018-06-26
First Post:
2016-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-21', 'studyFirstSubmitDate': '2016-12-02', 'studyFirstSubmitQcDate': '2018-05-23', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain perfusion', 'timeFrame': 'Change from baseline to 8 weeks supplementation', 'description': 'Arterial spin labelling using MRI, measure will be reported as ml/min'}], 'secondaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': 'Change from baseline to 8 weeks supplementation', 'description': 'Battery of cognitive function tasks assessing executive function, global cognitive function score will be reported'}, {'measure': 'Brain activation (fMRI)', 'timeFrame': 'Change from baseline to 8 weeks supplementation', 'description': 'fMRI using a hippocampal biased task'}, {'measure': 'Plasma nitrite concentration', 'timeFrame': 'Change from baseline to 8 weeks supplementation', 'description': 'Plasma sample analysed via chemiluminescence technique'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Effect of 8 weeks of cherry concentrate supplementation on cognitive function and brain perfusion in healthy older adults', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* physically inactive consuming 5 or less portions of fruit per day Addenbrookes cognitive examination III score \\>88\n\nExclusion Criteria:\n\n* physically active consuming more than 5 portions of fruit per day Addenbrookes cognitive examination III score \\<88 Contraindications for MRI'}, 'identificationModule': {'nctId': 'NCT03547102', 'briefTitle': 'Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Exeter'}, 'officialTitle': 'Effect of Cherry Concentrate on Brain Activation and Perfusion in Healthy Older Adults', 'orgStudyIdInfo': {'id': '115229/02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cherry concentrate', 'description': '8 weeks supplementation with montmorency cherry concentrate', 'interventionNames': ['Dietary Supplement: Cherry concentrate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo concentrate', 'description': '8 weeks supplementation with placebo isoenergetic cherry concentrate', 'interventionNames': ['Dietary Supplement: Placebo concentrate']}], 'interventions': [{'name': 'Cherry concentrate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Cherry concentrate']}, {'name': 'Placebo concentrate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo concentrate']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joanna L Bowtell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Exeter'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Exeter', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}