Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT04840160
Status:
COMPLETED
Last Update Posted:
2021-04-09
First Post:
2021-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Tart Cherry Juice Intervention on Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Participants supplied with treatment or placebo in a plastic container'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-08', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-08', 'lastUpdatePostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic and diastolic blood pressure', 'timeFrame': 'Change in blood pressure following 4 weeks intervention', 'description': 'Measurement of systolic and diastolic blood pressure before and after the intervention'}, {'measure': 'Arterial pulse wave velocity', 'timeFrame': 'Change in pulse wave velocity following 4 weeks intervention', 'description': 'Measurement of pulse wave velocity before and after the intervention'}, {'measure': 'Digital volume pulse', 'timeFrame': 'Change in digital volume pulse following 4 weeks intervention', 'description': 'Measurement of digital volume pulse before and after the intervention'}], 'secondaryOutcomes': [{'measure': 'Metabolomics', 'timeFrame': 'Changes to urinary metabolite profiles following 4 weeks intervention', 'description': 'Ion intensities of ca 5000 metabolites in urine samples before and after the intervention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cherry', 'anthocyanin', 'vascular function', 'metabolomics'], 'conditions': ['Dietary Exposure', 'Metabolic Disturbance']}, 'descriptionModule': {'briefSummary': 'Diets containing fruit rich in anthocyanins have been shown (in meta-analyses) to be beneficial for health, but intervention trials have shown inconsistent results. In this preliminary study we want to investigate the influence of a tart-cherry juice intervention on vascular function and explore metabolite profiles that may offer insight into their mechanism of action', 'detailedDescription': 'Cardiovascular disease (CVD) is the primary cause of morbidity and mortality. Tart cherries (TC) can positively impact major risk factors of CVD, activities thought to be related to their phytochemical content. However, data from human trials is less clear. TC have been shown to reduce systolic blood pressure (SBP) after acute, short-term and chronic intake, and to improve vascular dysfunction, presumably due to their antioxidant and anti-inflammatory activities. Other studies have not shown benefits of TC on SBP or vascular function and studies are difficult to interpret with different populations, dosing and durations being used as well as a lack of understanding for any underlying mechanisms. To account for the latter, the use of metabolomics has become increasingly popular in nutritional research. Therefore, the aim of this preliminary study was to characterise the effects of TC supplementation on vascular function with a 4-week intervention and explore if metabolomics can provide mechanistic evidence and this will inform for future chronic studies with TC juice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged 19-40\n* no diagnosed issues with the ability to consume fruit juice\n* no known food intolerances to fruits\n\nExclusion Criteria:\n\n* participants that are cigarette smokers\n* participants diagnosed with hypertension\n* participants diagnosed with any form of cardiometabolic diseases\n* participants that require any prescribed prescriptions excluding the contraceptive pill\n* participants that are regular consumers of cherries (\\>100 g/d)\n* participants that consume any antioxidant supplements'}, 'identificationModule': {'nctId': 'NCT04840160', 'briefTitle': 'Influence of Tart Cherry Juice Intervention on Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'Northumbria University'}, 'officialTitle': 'Influence of Tart Cherry Juice Intervention on Vascular Function and the Urinary Metabolite; a Preliminary Study to Inform Study Design', 'orgStudyIdInfo': {'id': 'lucymurray2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants supplied with 30 ml of a low fruit (\\<1%) cordial mixed with maltodextrin and protein diluted in 100 ml water twice daily, once in the morning and evening.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cherry juice', 'description': 'Participants supplied with 30 ml of a tart cherry juice concentrate (CherryActive, United Kingdom; (containing 36.8 mg of anthocyanins) diluted in 100 ml of water twice daily, once in the morning and evening.', 'interventionNames': ['Dietary Supplement: Cherry juice']}], 'interventions': [{'name': 'Cherry juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A tart cherry juice intervention', 'armGroupLabels': ['Cherry juice']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A tart cherry juice placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NE1 7ST', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Northumberland Building', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}], 'overallOfficials': [{'name': 'Glyn Howatson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northumbria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Research data will be shared on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northumbria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}