Pharmacokinetics of New Curcumin Formulations, Safety of New Curcumin Formulations
Conditions
Keywords
bioavailability, curcumin, pharmacokinetic, curcuma longa, age differences, sex differences
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.
Interventions
DIETARY_SUPPLEMENTcurcumin
80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals
Sponsors
German Federal Ministry of Education and Research
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
| Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
| Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
| Maximum plasma concentration (Cmax) of total curcumin [nmol/L] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
| Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
| Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
| Time to reach maximum plasma concentration (Tmax) of total curcumin [h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
| Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
| Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h] | 0, 0.5, 1, 2, 4, 6, 8 and 24 h post-dose | Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase |
Secondary
| Measure | Time frame |
|---|---|
| Serum alanine transaminase activity [U/L] | 0, 4, 24h post-dose |
| Serum gamma-glutamyl transferase activity [U/L] | 0, 4, 24h post-dose |
| Serum aspartate transaminase activity [U/L] | 0, 4, 24h post-dose |
| Serum alkaline phosphatase activity [U/L] | 0, 4, 24h post-dose |
| Serum bilirubin [mg/dL] | 0, 4, 24h post-dose |
| Serum uric acid [mg/dL] | 0, 4, 24h post-dose |
| Serum creatinine [mg/dL] | 0, 4, 24h post-dose |
| Serum total cholesterol [mg/dL] | 0, 4, 24h post-dose |
| Serum HDL cholesterol [mg/dL] | 0, 4, 24h post-dose |
| Serum LDL cholesterol [mg/dL] | 0, 4, 24h post-dose |
| Serum triacylglycerols [mg/dL] | 0, 4, 24h post-dose |
Countries
Germany
Outcome results
None listed