Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT03746158
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2018-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interindividual Variation in Excretion of Curcumin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-14', 'studyFirstSubmitDate': '2018-11-15', 'studyFirstSubmitQcDate': '2018-11-15', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the concentration of curcumin and its metabolites in the human fecal samples.', 'timeFrame': '3-4 weeks', 'description': 'Utilize LC-MSMS to identify and quantify the curcumin and its metabolites in the subjects fecal samples.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metabolites', 'Gut Microbiota']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to elucidate the interindividual variations in excretion of curcumin and its metabolites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-30 year old healthy adults\n\nExclusion Criteria:\n\n* Exclusion criteria included those who are \\<18 or \\>30 years old, have a BMI of \\<20 or \\>29 kg/m2, have a weight change \\>4.5 kg in the past 3 months, exceed exercise activities of a curcumin level over the past 3 months, have any diseases, especially intestinal disorders, had abnormal liver or kidney function tests. Those who smoke, consume more than two alcoholic drinks per day, use medication affecting gut microbiota profile (e.g., antibiotics and probiotics) in past three months will also be excluded.\n* Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT03746158', 'briefTitle': 'Interindividual Variation in Excretion of Curcumin', 'organization': {'class': 'OTHER', 'fullName': 'University of Massachusetts, Amherst'}, 'officialTitle': 'University of Massachusetts Amherst', 'orgStudyIdInfo': {'id': '2018-4937'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curcumin', 'description': 'subjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal).', 'interventionNames': ['Dietary Supplement: curcumin']}], 'interventions': [{'name': 'curcumin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'subjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal).', 'armGroupLabels': ['Curcumin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01003', 'city': 'Amherst', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Institute for Applied Life Sciences', 'geoPoint': {'lat': 42.36723, 'lon': -72.51852}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Massachusetts, Amherst', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}