Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:23 AM
Study NCT ID:
NCT01528202
Status:
COMPLETED
Last Update Posted:
2012-02-07
First Post:
2012-02-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tart Cherries and Melatonin Content
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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-03', 'studyFirstSubmitDate': '2012-02-03', 'studyFirstSubmitQcDate': '2012-02-03', 'lastUpdatePostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'urinary 6-sulphatoxymelatonin', 'timeFrame': 'continually for 48 hours', 'description': 'urinary 6-sulphatoxymelatonin is the primary metabolite of melatonin and provides a sarrogate marker of melatonin metabolism. By measuring over a 48 h period it is possible to examine the circadian rhythm of melatonin.'}], 'secondaryOutcomes': [{'measure': 'Sleep quality', 'timeFrame': 'continually throughout the duration of the study', 'description': 'Acti watches quantitively measure sleep and activity of participants, whereas slep recall provides a retrospective and subjective m,easure of sleep quality.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sleep, circadian cycle, melatonin'], 'conditions': ['Sleep']}, 'descriptionModule': {'briefSummary': 'The aim of this investigation was to examine the effects of tart Montmorency cherry juice on urinary 6-sulfatoxymelatonin and sleep quality using a double-blind, placebo-controlled, cross-over design.', 'detailedDescription': 'The aim of the study is to examine the efficacy of tart cherry juice on sleep quality, quantity, and timing. Naturally circulating melatonin is instrumental in regulating sleep/wake schedules. Tart Montmorency cherries (Prunus Cerasus) contain high levels of melatonin and may be a useful intervention to supplement for realignment of circadian phase and by increasing the robustness of circadian amplitude. In normal healthy adults, with experimentally induced phase advanced circadian misalignment, the administration of a 3mg supplement of melatonin significantly increased sleep architecture characteristics. In this study we want to examine the efficacy of tart cherry juice in increasing urinary levels of melatonin and the subsequent impact this will have on sleep parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '39 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Equal numbers of healthy, non-pathological males and females aged between 18-39.\n\nExclusion Criteria:\n\n* history of epilepsy, current episode of major depressive disorder or anxiety disorder, or a current sleep problem or an inability to comprehend English, travel over two time zones within the last six months, excessive alcohol (over 3 units per day) or caffeine consumption (more than 6 caffeinated drinks or 1 after 6pm), a smoker, a shift worker, a familial history of diabetes, users of medication or supplements, or if the participant is pregnant or currently lactating.'}, 'identificationModule': {'nctId': 'NCT01528202', 'briefTitle': 'Tart Cherries and Melatonin Content', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'Effect of Tart Cherry Juice (Prunus Cerasus) on Melatonin Levels and Sleep Quality', 'orgStudyIdInfo': {'id': 'SLS_SUB60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Baseline placebo', 'description': 'measures taken before administration of placebo'}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': "Placebo intervention given after 'baseline placebo' arm", 'interventionNames': ['Dietary Supplement: Fruit juice cordial']}, {'type': 'NO_INTERVENTION', 'label': 'baseline cherry juice', 'description': 'measures taken before the cherry juice intervention'}, {'type': 'EXPERIMENTAL', 'label': 'cherry juice', 'description': "trial where cherry juice is taken following the 'baseline cherry juice' arm", 'interventionNames': ['Dietary Supplement: Cherry juice']}], 'interventions': [{'name': 'Cherry juice', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['CherryActive concentrate'], 'description': '30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.', 'armGroupLabels': ['cherry juice']}, {'name': 'Fruit juice cordial', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ["Apple and blackcurrent squash (0164 9338). Sainsbry's Supermarkets Ltd."], 'description': 'fruit flavoured juice concentrate', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 8ST', 'city': 'Newcastle upon Tyne', 'state': 'Tyne and Wear', 'country': 'United Kingdom', 'facility': 'Northumbria University', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Glyn Howatson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Surrey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Laboratory Director', 'investigatorFullName': 'Dr. Glyn Howatson', 'investigatorAffiliation': 'Northumbria University'}}}}