Pharmacokinetics After Oral Intake, Safety After Oral Intake
Conditions
Keywords
Bioavailability, Pharmacokinetics, Curcumin, Demethoxycurcumin, Bisdemethoxycurcumin
Brief summary
The curcuminoids curcumin, demethoxycurcumin and bisdemethoxycurcumin can be found in the rhizome of turmeric (Curcuma longa). Curcumin is widespread used for colouring foods. Based on its natural low bioavailability and the number of its effects on human health, several approaches such as increasing its water solubility or inhibiting its metabolism were taken to improve its bioavailability. Pharmacokinetics of curcumin from various supplements using those different mechanisms have been compared to the one of native curcumin. The investigator's study here will compare the bioavailability of curcumin from eight different curcumin formulations with native curcumin and between themselves. The study will folllow a single dose (in form of curcumin formulations, normalized to 207 mg curcumin), placebo-controlled, randomized, double-blind, nine-armed crossover study design with ≥ 1-week washout periods. Plasma samples will be collected at intervals up to 24 hours after intake. Investigators will compare the pharmacokinetics between the different curcumin formulations and to native curcumin.
Interventions
DIETARY_SUPPLEMENTNative turmeric extract
207 mg curcumin
DIETARY_SUPPLEMENTNative turmeric extract with 7-9% volatile turmeric oils
207 mg curcumin
DIETARY_SUPPLEMENTTurmeric extract plus mixture of phytochemicals
207 mg curcumin
DIETARY_SUPPLEMENTCyclodextrin complex of curcuminoids
207 mg curcumin
DIETARY_SUPPLEMENTTurmeric oleoresin
207 mg curcumin
DIETARY_SUPPLEMENTLiposomal curcumin
207 mg curcumin
DIETARY_SUPPLEMENTPhytosomal curcumin
207 mg curcumin
DIETARY_SUPPLEMENTMicellar turmeric extract
207 mg curcumin
Sponsors
University of Hohenheim
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy Volunteers with blood chemistry values within normal ranges * Body mass index in a normal range
Exclusion criteria
* Pregnancy or lactation * Alcohol and or drug abuse * Use of dietary supplements or any medications except contraceptives * Any known malignant, metabolic and endocrine diseases * Previous cardiac infarction * Dementia * Blood pressure \>140/90 mmHg * Resting heart rate not within 50 to 90 beats per minute * Participation in a clinical trial within the past 6 weeks * Smoking * Physical activity of more than 5 h per wk
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total bisdemethoxycurcumin after deconjugation with β-glucuronidase |
| Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total curcumin after deconjugation with β-glucuronidase |
| Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total demethoxycurcumin after deconjugation with β-glucuronidase |
| Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total bisdemethoxycurcumin after deconjugation with β-glucuronidase |
| Maximum plasma concentration (Cmax) of total curcumin [nmol/L] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total curcumin after deconjugation with β-glucuronidase |
| Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total demethoxycurcumin after deconjugation with β-glucuronidase |
| Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total bisdemethoxycurcumin after deconjugation with β-glucuronidase |
| Time to reach maximum plasma concentration (Tmax) of total curcumin [h] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total curcumin after deconjugation with β-glucuronidase |
| Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h] | 0, 1, 2, 4, 6, 8 and 24 hours post dose | Total demethoxycurcumin after deconjugation with β-glucuronidase |
Countries
Germany
Outcome results
None listed