To investigate the metabolism of curcumin in healthy volunteers and the effects of piprine and a lipid liquid formulation.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Therapeutic and nontherapeutic effects (excl toxicity)
- Vascular disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Kinetic parameters of curcumin: AUC, clearance, volume of distribution,
elimination half-life and possible Cmax and Tmax concentrations.
Secondary outcome
Kinetic parameters of curcumin and piperine of each of the 5 products.
Influence of curcumin and piperine on different biochemical parameters.
Background summary
The interest in curcumin is growing and despite all the pre-clinical evidence
the effectiveness in clinical trials is sometimes limited. It is assumed that
the clinical effect of curcumin is poor due to tis low bioavailability.
Piperine or a lipid liquid formulation may increase the bioavailability of
curcumin. We expect that also metabolism could play an important part. In this
study we want to investigate the metabolism of curcumin further after
controlled intake of curcumin and investigate the effect of piperine or a
polysorbate formulation (as liquid lipid formulation) on the metabolism of
curcumin.
Study objective
To investigate the metabolism of curcumin in healthy volunteers and the effects
of piprine and a lipid liquid formulation.
Study design
Single center, open-label, randomised, cross-over intervention study.
Intervention
During 5 investigation fases, 5 different curcumin products will be taken
orally. Each product will be taken once.
Study burden and risks
The risk is associated with this study is considered negligible.
The burden contains an screeningsvisit with an bloodwithdrawal.
The investigation contains 5 investigation fases. Each containing: three days
following a diet, a hospital day of 9 hours with multiple bloodwithdrawals and
a hospital visit the next day for 1 blood withdrawal and collection of urine
samples.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
* Major illness in the past 3 months
* Gastrointestinal disease
* 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. With the exclusion of (non)prescription drugs used for their local
effect and thus have no influence on the kinetics of curcumin.
* 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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL61195.018.17 |
| OMON | NL-OMON23684 |