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To investigate the absorption and conversion of curcumin in the human body of healthy adult male patients


- candidate number27995
- NTR NumberNTR6741
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-okt-2017
- Secondary IDsNL61195.018.17 METC AMC
- Public TitleTo investigate the absorption and conversion of curcumin in the human body of healthy adult male patients
- Scientific TitleMetabolism of curcumin in healthy volunteers
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedCurcumin, Pharmacokinetics
- Inclusion criteria- Healthy male, age ≥ 18 years
- Able to give written informed consent
- Willing to follow the dietary regimens
- Able to complete the entire study
- Exclusion criteria- Inability to give informed consent
- Major illness in the past 3 months
- Gasrtointestinal disease that may influence the absorption of the supplements
- History of cholecystectomy or other bile duct abnormalities
- Metabolic or endocrine diseases
- Drug abuse or alcoholism (>3 units of alcohol per day)
- Use of prescription or non-prescription drugs and herbal or dietary supplements within 30 days prior to the first administration of curcumin supplement.
- Use of tobacco products
- High usage of curcumin and black pepper in daily food/beverages
- Known intolerance for curcumin or black pepper
- Participation in another clinical trial in the 3 months prior to the start of the study
- Use of alcohol for at least 3 days prior to each study day
- Use of caffeine products for at least 3 days prior to each study day
- Strenuous exercise for at least 3 days prior to each study day, defined as more than 1 hour exercise per day
- Eating/drinking of grapefruit and grapefruit-containing products or star fruit for at least 3 days prior to each study day
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2017
- planned closingdate
- Target number of participants9
- InterventionsCurcumin-C3 complex 600 mg
Curcumin-C3 complex 2400 mg
Curcumin-C3 complex with piperine 2400/20 mg Curcumine complex formulated in polysorbate 80
- Primary outcomeTo investigate the kinetics and metabolism of curcumin over time in healthy volunteers after intake of different curcumin products and the effect of piperine and a lipid formulation.
- Secondary outcomeTo determine if addition of piperine increase the bioavailability of active curcumin and if there is a change in kinetic and metabolic profile.
To determine if a liquid commercial curcumin product, with a claimed 185x higher bioavailability, indeed increases the bioavailability of curcumin and if there is a change in kinetic and metabolic profile.
To investigate if a single dose of curcumin would influence different biochemical parameters.
- TimepointsBloodsamples will be taken at T=0, t=0.25, t=0.5, t=0.75, t=1, t=1.5, t=2, t=4, t=8, t=24.
Urine willl be collected during 24 hours.
Feces will be collected during 48 hours.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES M.A.G.M. Kroon
- CONTACT for SCIENTIFIC QUERIES M.A.G.M. Kroon
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summaryIt is assumed that the clinical effect of curcumin is poor due to its low bioavailability and that piperine, or a lipid formulation may increase the bioavailability of curcumin. Nine healthy male volunteers aged 18 years or older are randomized in 3 arms. Each arm contains the following four forumulations:
Curcumin-C3 complex 600 mg
Curcumin-C3 complex 2400 mg
Curcumin-C3 complex with piperine 2400/20 mg Curcumine complex formulated in polysorbate 80
After intake bloodsamples, urine and feces will be collected over a certain timeframe. The following components will be analyzed by LC/MS/MS for pharmacokinetic parameters: curcumin + two other curcuminoids, tetrahydrocurcumin, piperine and the conjugated metabolites of the above mentioned components.
- Main changes (audit trail)
- RECORD9-okt-2017 - 21-okt-2017


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