Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2026-02-13 @ 1:09 PM
Study NCT ID:
NCT01982734
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2013-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improved Oral Bioavailability of Curcumin Incorporated Into Micelles
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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2013-11-05', 'studyFirstSubmitQcDate': '2013-11-05', 'lastUpdatePostDateStruct': {'date': '2016-10-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}, {'measure': 'Maximum plasma concentration (Cmax) of total curcumin [nmol/L]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}, {'measure': 'Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}, {'measure': 'Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}, {'measure': 'Time to reach maximum plasma concentration (Tmax) of total curcumin [h]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}, {'measure': 'Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}, {'measure': 'Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]', 'timeFrame': '0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose', 'description': 'Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase'}], 'secondaryOutcomes': [{'measure': 'Serum aspartate transaminase activity [U/L]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum alanine transaminase activity [U/L]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum gamma-glutamyl transferase activity [U/L]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum alkaline phosphatase activity [U/L]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum bilirubin [mg/dL]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum uric acid [mg/dL]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum creatinine [mg/dL]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum total cholesterol [mg/dL]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum HDL cholesterol [mg/dL]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum LDL cholesterol [mg/dL]', 'timeFrame': '0, 4, 24h post-dose'}, {'measure': 'Serum triacylglycerols [mg/dL]', 'timeFrame': '0, 4, 24h post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['bioavailability', 'curcumin', 'pharmacokinetic', 'curcuma longa', 'age differences', 'sex differences'], 'conditions': ['Pharmacokinetics of New Curcumin Formulations', 'Safety of New Curcumin Formulations']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Kocher, A., Schiborr, C., Behnam, D., & Frank, J. (2015). The oral bioavailability of curcuminoids in healthy humans is markedly enhanced by micellar solubilisation but not further improved by simultaneous ingestion of sesamin, ferulic acid, naringenin and xanthohumol. J Funct Foods 14: 183-19.'}], 'seeAlsoLinks': [{'url': 'http://www.nutrition-research.de/', 'label': 'Website of the research group'}]}, 'descriptionModule': {'briefSummary': 'Curcumin, a lipophilic polyphenol derived from the plant curcuma longa possesses numerous health-promoting activities. The oral bioavailability of curcumin is low due to its poor aqueous solubility, limited gastrointestinal absorption, rapid metabolism and excretion. Therefore, we tested, in a randomized crossover study, simultaneous application of phytochemicals and micellar solubilisation, alone and together, as strategies to enhance the absorption of curcumin into the body. Furthermore, we investigated age and sex differences in curcumin pharmacokinetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers with routine blood chemistry values within the normal ranges\n* Age: 18-35 years or \\> 60 years\n\nExclusion Criteria:\n\n* overweight (BMI \\>30 kg/m2)\n* metabolic and endocrine diseases\n* pregnancy\n* lactation\n* drug abuse\n* use of dietary supplements or any form of medication (with the exception of oral contraceptives)\n* smoking\n* frequent alcohol consumption (\\>20 g ethanol/d)\n* adherence to a restrictive dietary regimen\n* physical activity of more than 5 h/wk'}, 'identificationModule': {'nctId': 'NCT01982734', 'briefTitle': 'Improved Oral Bioavailability of Curcumin Incorporated Into Micelles', 'organization': {'class': 'OTHER', 'fullName': 'University of Hohenheim'}, 'officialTitle': 'Novel Strategies for the Enhancement of the Potency of Nutraceuticals With Low Oral Bioavailability and Their Application in Novel Functional Foods for Optimum Protection of the Aging Brain', 'orgStudyIdInfo': {'id': '051113-HS2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Native curcumin', 'description': '80 mg curcumin as native powder', 'interventionNames': ['Dietary Supplement: curcumin']}, {'type': 'EXPERIMENTAL', 'label': 'Native curcumin plus phytochemicals', 'description': '80 mg curcumin as native powder plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid and 40 mg xanthohumol', 'interventionNames': ['Dietary Supplement: curcumin']}, {'type': 'EXPERIMENTAL', 'label': 'Curcumin micelles', 'description': '80 mg curcumin incorporated into liquid micelles', 'interventionNames': ['Dietary Supplement: curcumin']}, {'type': 'EXPERIMENTAL', 'label': 'Curcumin micelles plus phytochemicals', 'description': '80 mg curcumin incorporated into liquid micelles plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid, 40 mg xanthohumol incorporated into micelles', 'interventionNames': ['Dietary Supplement: curcumin']}], 'interventions': [{'name': 'curcumin', 'type': 'DIETARY_SUPPLEMENT', 'description': '80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals', 'armGroupLabels': ['Curcumin micelles', 'Curcumin micelles plus phytochemicals', 'Native curcumin', 'Native curcumin plus phytochemicals']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70599', 'city': 'Stuttgart', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University of Hohenheim', 'geoPoint': {'lat': 48.78232, 'lon': 9.17702}}], 'overallOfficials': [{'name': 'Jan Frank, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Hohenheim, Stuttgart, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Hohenheim', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Federal Ministry of Education and Research', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}