Clinical trial NCT03530436: Comparison of Curcumin Bioavailability
Official title: Comparison of the Bioavailability of Different Curcumin Formulations in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety After Oral Intake
Pharmacokinetics After Oral Intake
Keywords: Bioavailability
Pharmacokinetics
Curcumin
Demethoxycurcumin
Bisdemethoxycurcumin
Lead sponsor: University of Hohenheim
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
measure: Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
measure: Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
measure: Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
measure: Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
measure: Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
measure: Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
measure: Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
measure: Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
timeFrame: 0, 1, 2, 4, 6, 8 and 24 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: University of Hohenheim
state: Baden-Württemberg
Study officials:
affiliation: University of Hohenheim
name: Jan Frank, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: