Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-17 @ 2:44 AM
Study NCT ID:
NCT02922920
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2016-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Tart Cherry Juice on the Body
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-03', 'studyFirstSubmitDate': '2016-09-20', 'studyFirstSubmitQcDate': '2016-10-03', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognitive function', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Change from baseline in cognitive test performance at 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular risk factors', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Fasting blood samples were collected at baseline and 12 weeks. Change from baseline in cardiovascular risk factors including blood lipid profiles, atherogenic risk ratios, blood glucose, hemoglobin A1c, insulin, and blood pressure at 12 weeks.'}, {'measure': 'Oxidative stress markers', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Fasting blood samples were collected at baseline and 12 weeks. Change from baseline in plasma 8-oxoguanine (ng/ml), plasma 8-hydroxy-2deoxy-guanosine (ng/mL), plasma hydroxynonenal (ng/ml), and plasma malondialdehyde (pmole/L) at 12 weeks.'}, {'measure': 'Inflammatory markers', 'timeFrame': 'Baseline and 12 weeks', 'description': 'Fasting blood samples were collected at baseline and 12 weeks. Change from baseline in plasma tumor-necrosis factor-α (pg/mL) and plasma high-sensitivity C-reactive protein (ng/mL) at 12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cardiovascular Risk Factors', 'Age-Related Cognitive Decline']}, 'descriptionModule': {'briefSummary': 'Tart cherries are a rich source of antioxidants. Studies have shown that tart cherries exert anti-oxidative and anti-inflammatory properties. The purpose of this study is to learn about the effects of drinking tart cherry juice on cardiovascular and cognitive health.', 'detailedDescription': 'Thirty-seven older adults were randomly assigned to drink 16 oz per day of either tart cherry juice or placebo drink for 12 weeks. Blood and urine samples were collected at baseline and 12 weeks to assess biomarkers. Physical activity and 3-day diet records were also collected throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n• Age 65-80\n\nExclusion Criteria:\n\n* Allergic to tart cherries\n* Heavy smoker\n* Taking medications that affect cognitive function\n* History of neurological disorders\n* History of traumatic brain injury\n* History of stroke\n* Clinical diagnosis of diabetes\n* Clinical diagnosis of Alzheimer's Disease/Dementia\n* GI disease\n* Kidney disease\n* Liver disease\n* Cancer"}, 'identificationModule': {'nctId': 'NCT02922920', 'briefTitle': 'Effects of Tart Cherry Juice on the Body', 'organization': {'class': 'OTHER', 'fullName': 'University of Delaware'}, 'officialTitle': 'Effects of Tart Cherry Juice on the Body', 'orgStudyIdInfo': {'id': '15A00149'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tart cherry juice', 'description': 'Participants consumed 16 fl. oz of tart cherry juice daily for 12 weeks.', 'interventionNames': ['Other: Tart cherry juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo juice', 'description': 'Participants consumed 16 fl. oz of placebo daily for 12 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Tart cherry juice', 'type': 'OTHER', 'description': '16 fl. oz of tart cherry juice', 'armGroupLabels': ['Tart cherry juice']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '16 fl. oz of placebo', 'armGroupLabels': ['Placebo juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19716', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'University of Delaware', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}], 'overallOfficials': [{'name': 'Sheau Ching Chai, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Delaware'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Delaware', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sheau Ching Chai', 'investigatorAffiliation': 'University of Delaware'}}}}