Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-01 @ 10:53 AM
Study NCT ID:
NCT06202157
Status:
COMPLETED
Last Update Posted:
2024-01-11
First Post:
2024-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metabolic Differences Between Dihydroberberine and Micellar Berberine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C039639', 'term': 'dihydroberberine'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-02', 'studyFirstSubmitDate': '2024-01-02', 'studyFirstSubmitQcDate': '2024-01-02', 'lastUpdatePostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC: the area under the concentration-time curve', 'timeFrame': 'at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.', 'description': 'For each berberine metabolite, PK parameters such as Area Under Curve (AUC) of the blood concentrations over a 24-hour period are reported.'}, {'measure': 'Cmax: the maximum blood concentration', 'timeFrame': 'at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.', 'description': 'For each berberine metabolite, PK parameters such as the maximum blood concentration (Cmax) are reported.'}, {'measure': 'Tmax: the time at which Cmax is reached', 'timeFrame': 'at baseline (t=0 hours; before intervention), at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.', 'description': 'For each berberine metabolite, PK parameters such as Tmax, the time at which Cmax is reached, are reported.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['metabolites', 'berberine', 'micellar', 'dihydroberberine', 'pharmacokinetics'], 'conditions': ['Phase I and Phase II Metabolites of Berberine']}, 'descriptionModule': {'briefSummary': 'Differences in metabolites of dihydroberberine (DHB) and micellar berberine (LipoMicel®, LMB) are investigated through a randomized study involving human volunteers. Over a 24-hour period, blood samples are collected and subjected to Ultra High-Performance Liquid Chromatography-High Resolution Mass Spectrometry (UHPLC-HRMS) analysis to quantify the concentrations of berberine and its metabolites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 21 or older\n* healthy, good physical condition\n\nExclusion Criteria:\n\n* Pregnancy or breast-feeding\n* Gastrointestinal conditions\n* Acute or chronic liver disease\n* Acute or chronic kidney disease\n* Acute or chronic cardiovascular disease\n* Hematological disease\n* Diabetes\n* Allergy or Intolerance to gluten\n* Allergy or Intolerance to Berberine\n* Use of any form of nicotine or tobacco\n* Alcohol and substance abuse history\n* Use of medications (e.g., blood sugar-lowering agents, or statins)\n* Use of Berberine supplements\n* Participation in another investigational study'}, 'identificationModule': {'nctId': 'NCT06202157', 'briefTitle': 'Metabolic Differences Between Dihydroberberine and Micellar Berberine', 'organization': {'class': 'INDUSTRY', 'fullName': 'Factors Group of Nutritional Companies Inc.'}, 'officialTitle': 'Metabolic Differences Between Dihydroberberine and Micellar Berberine in Humans', 'orgStudyIdInfo': {'id': 'RR401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LMB (LipoMicel Berberine)', 'interventionNames': ['Other: LMB']}, {'type': 'EXPERIMENTAL', 'label': 'DHB (Dihydroberberine)', 'interventionNames': ['Other: DHB']}], 'interventions': [{'name': 'LMB', 'type': 'OTHER', 'otherNames': ['LipoMicel Berberine'], 'description': 'A baseline blood sample (t=0) is collected from each participant prior to the intervention (LMB), and subsequent blood samples are collected at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.', 'armGroupLabels': ['LMB (LipoMicel Berberine)']}, {'name': 'DHB', 'type': 'OTHER', 'otherNames': ['Dihydroberberine'], 'description': 'A baseline blood sample (t=0) is collected from each participant prior to the intervention (DHB), and subsequent blood samples are collected at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours post-intervention.', 'armGroupLabels': ['DHB (Dihydroberberine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V3N 4S9', 'city': 'Burnaby', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'ISURA', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Factors Group of Nutritional Companies Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Isura', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}