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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

April 25, 2018

Completed

26 days until next milestone

First Posted

Study publicly available on registry

May 21, 2018

Completed

17 days until next milestone

Study Start

First participant enrolled

June 7, 2018

Completed

2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2018

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2018

Completed

Last Updated

January 10, 2019

Status Verified

January 1, 2019

Enrollment Period

2 months

First QC Date

April 25, 2018

Last Update Submit

January 8, 2019

Conditions

Safety After Oral Intake Pharmacokinetics After Oral Intake

Keywords

BioavailabilityPharmacokineticsCurcuminDemethoxycurcuminBisdemethoxycurcumin

Outcome Measures

Primary Outcomes (9)

Mean area under the curve (AUC) of plasma concentration vs. time of total curcumin [nmol/L*h]
Total curcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total demethoxycurcumin [nmol/L*h]
Total demethoxycurcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose
Mean area under the curve (AUC) of plasma concentration vs. time of total bisdemethoxycurcumin [nmol/L*h]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total curcumin [nmol/L]
Total curcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]
Total demethoxycurcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose
Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total curcumin [h]
Total curcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]
Total demethoxycurcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose
Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]
Total bisdemethoxycurcumin after deconjugation with β-glucuronidase
0, 1, 2, 4, 6, 8 and 24 hours post dose

Study Arms (8)

Native turmeric extract

OTHER

6 capsules of native curcumin (207 mg curcumin)

Dietary Supplement: Native turmeric extract