Clinical trial NCT01982734: Improved Oral Bioavailability of Curcumin Incorporated Into Micelles
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Pharmacokinetics of New Curcumin Formulations
Safety of New Curcumin Formulations
Keywords: bioavailability
curcumin
pharmacokinetic
curcuma longa
age differences
sex differences
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
Collaborators: name: German Federal Ministry of Education and Research
First posted: 2013-11-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers with routine blood chemistry values within the normal ranges
* Age: 18-35 years or \> 60 years

Exclusion Criteria:

* overweight (BMI \>30 kg/m2)
* metabolic and endocrine diseases
* pregnancy
* lactation
* drug abuse
* use of dietary supplements or any form of medication (with the exception of oral contraceptives)
* smoking
* frequent alcohol consumption (\>20 g ethanol/d)
* adherence to a restrictive dietary regimen
* physical activity of more than 5 h/wk

Primary outcomes:
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
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
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
measure: Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
measure: Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
measure: Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
timeFrame: 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose
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
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
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
Secondary outcomes:
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
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim, Stuttgart, Germany
name: Jan Frank, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.