Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01677169
Status:
COMPLETED
Last Update Posted:
2019-09-11
First Post:
2012-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 317}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2006-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-09', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2012-08-30', 'lastUpdatePostDateStruct': {'date': '2019-09-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LOOH and MDA-DNA adducts', 'timeFrame': '1 month', 'description': 'LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention.'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '1 month', 'description': 'Adverse health events'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['DNA Damage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH) and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral blood lymphocytes of cigarette smokers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 to 65 years in age, smoker of more than 20 cigarettes per day, a smoking history exceeding one year, and willing to complete a one month trial.\n\nExclusion Criteria:\n\n* concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins'}, 'identificationModule': {'nctId': 'NCT01677169', 'briefTitle': 'Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tahitian Noni International, Inc.'}, 'officialTitle': 'Double Blind, Randomized, Placebo-controlled Clinical Trial of the Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Current Heavy Smokers', 'orgStudyIdInfo': {'id': 'TNI-UIC-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '59 mL noni juice', 'description': 'Ingestion of 59 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) twice daily (118 mL daily total) for 30 days.', 'interventionNames': ['Dietary Supplement: Noni juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Ingestion of 59 mL of placebo (mixture of grape and blueberry juices and natural cheese flavor) twice daily (118 mL daily total) for 30 days.', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '29.5 mL noni dose', 'description': 'Ingestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days.', 'interventionNames': ['Dietary Supplement: Noni juice']}], 'interventions': [{'name': 'Noni juice', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Tahitian Noni® Juice', 'Tahitian Noni® Original Bioactive', 'Thrive Adaptogenics Original'], 'description': 'Ingestion of noni juice, a source of iridoids, daily for 30 days.', 'armGroupLabels': ['29.5 mL noni dose', '59 mL noni juice']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61107', 'city': 'Rockford', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois College of Medicine at Rockford', 'geoPoint': {'lat': 42.27113, 'lon': -89.094}}], 'overallOfficials': [{'name': 'Mian-ying Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tahitian Noni International, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'University of Illinois at Chicago', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}