Ignite Creation Date:
2025-12-24 @ 9:43 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT05349032
Status:
UNKNOWN
Last Update Posted:
2022-04-27
First Post:
2022-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessing the Bioavailability of Leading Phytonutrient Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2022-04-21', 'studyFirstSubmitQcDate': '2022-04-21', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioavailability', 'timeFrame': '0, 1, 2, 4, and 12 hours', 'description': 'Blood Plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infalmmation', 'bioavailability'], 'conditions': ['Inflammation']}, 'referencesModule': {'references': [{'pmid': '30006023', 'type': 'RESULT', 'citation': 'Jamwal R. Bioavailable curcumin formulations: A review of pharmacokinetic studies in healthy volunteers. J Integr Med. 2018 Nov;16(6):367-374. doi: 10.1016/j.joim.2018.07.001. Epub 2018 Jul 4.'}]}, 'descriptionModule': {'briefSummary': 'This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. The study will secondarily look at inflammatory markers in the urine to determine any change.', 'detailedDescription': 'This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. 120 mg of curcumin from brands Meriva, CurcElite, Lonvida, UltraCur, NovaSol. The study will secondarily look at inflammatory markers in the urine to determine any change.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age and gender\n\nExclusion Criteria:\n\n* Cannot take any phytonutrient or curcumin supplement five days prior to commencement.'}, 'identificationModule': {'nctId': 'NCT05349032', 'briefTitle': 'Assessing the Bioavailability of Leading Phytonutrient Products', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epiceutical Labs'}, 'officialTitle': 'Assessing the Bioavailability of Leading Phytonutrient Products', 'orgStudyIdInfo': {'id': '101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Meriva', 'description': '120 mg of curcumin in Meriva.', 'interventionNames': ['Dietary Supplement: Curcumin']}, {'type': 'OTHER', 'label': 'Longvida', 'description': '120 mg of curcumin Longvida.', 'interventionNames': ['Dietary Supplement: Curcumin']}, {'type': 'OTHER', 'label': 'NovaSol', 'description': '120 mg of curcumin NovaSol', 'interventionNames': ['Dietary Supplement: Curcumin']}, {'type': 'OTHER', 'label': 'CurcElite', 'description': '120 mg of curcumin CurcElite', 'interventionNames': ['Dietary Supplement: Curcumin']}, {'type': 'OTHER', 'label': 'UltaCur', 'description': '120 mg of curcumin Ultracur', 'interventionNames': ['Dietary Supplement: Curcumin']}], 'interventions': [{'name': 'Curcumin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oral supplement', 'armGroupLabels': ['CurcElite', 'Longvida', 'Meriva', 'NovaSol', 'UltaCur']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22902', 'city': 'Charlottesville', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David Roberts, MPH', 'role': 'CONTACT', 'email': 'droberts@brocelite.com', 'phone': '434-981-8629'}], 'facility': 'David Roberts', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}], 'centralContacts': [{'name': 'David Roberts, MPH', 'role': 'CONTACT', 'email': 'research@epiceuticallabs.com', 'phone': '810777687'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Blood plasma and urine samples will be collected for five different times over five different supplements.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epiceutical Labs', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}