NCT01925287

Brief Summary

Background: The oral bioavailability of curcumin is low due to its limited intestinal uptake, rapid metabolism and excretion from the body. Considering its potent reported health-beneficial properties, researchers have tried to increase its bioavailability as a means to enhance its biological activities. Objective: The aim of the project was to develop novel curcumin formulations with enhanced oral bioavailability and to study the safety of the formulations and potential sex-differences in humans. Design: In this single-blind crossover study with three arms separated by ≥1-week washout periods, healthy subjects (13 women, 10 men) were provided standardized meals and took, in random order, a single oral dose of 500 mg curcumin as native powder, micronized powder, or liquid micelles. Blood and urine samples were collected in intervals for 24 h and total curcumin, demethoxycurcumin, and bis-demethoxycurcumin were quantified.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Oct 2011

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

Study Start

First participant enrolled

October 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 13, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2013

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

1.8 years

First QC Date

August 13, 2013

Last Update Submit

October 24, 2016

Conditions

Pharmacokinetics of Novel Curcumin FormulationsSafety of Novel Curcumin Formulations

Keywords

bioavailabilitycurcumincurcuma longahealthy humanssafetysex differences

Outcome Measures

Primary Outcomes (9)

  • Area under the plasma concentration versus time curve (AUC) of total curcumin [nmol/L*h]

    Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

  • Area under the plasma concentration versus time curve (AUC) of total demethoxycurcumin [nmol/L*h]

    Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

  • Area under the plasma concentration versus time curve (AUC) of total bisdemethoxycurcumin [nmol/L*h]

    Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

  • Maximum plasma concentration (Cmax) of total curcumin [nmol/L]

    Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

  • Maximum plasma concentration (Cmax) of total demethoxycurcumin [nmol/L]

    Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

  • Maximum plasma concentration (Cmax) of total bisdemethoxycurcumin [nmol/L]

    Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

  • Time to reach maximum plasma concentration (Tmax) of total curcumin [h]

    Total curcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

  • Time to reach maximum plasma concentration (Tmax) of total demethoxycurcumin [h]

    Total demethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

  • Time to reach maximum plasma concentration (Tmax) of total bisdemethoxycurcumin [h]

    Total bisdemethoxycurcumin was determined after deconjugation with beta-glucuronidase/sulphatase

    0, 0.5, 1, 1.5, 2, 4, 6, 8 and 24 h post-dose

Secondary Outcomes (39)

  • Serum aspartate transaminase activity [U/L]

    Baseline

  • Serum aspartate transaminase activity [U/L]

    4 h post-dose

  • Serum aspartate transaminase activity [U/L]

    24 h post-dose

  • Serum alanine transaminase activity [U/L]

    Baseline

  • Serum alanine transaminase activity [U/L]

    4 h post-dose

  • +34 more secondary outcomes

Study Arms (3)

Native curcumin powder

ACTIVE COMPARATOR

500 mg curcumin as native powder

Dietary Supplement: curcumin

Micronized curcumin powder

EXPERIMENTAL

500 mg curcumin as micronized powder

Dietary Supplement: curcumin

Curcumin micelles

EXPERIMENTAL

500 mg curcumin incorporated into liquid micelles

Dietary Supplement: curcumin

Interventions

curcuminDIETARY_SUPPLEMENT

500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles

Curcumin micellesMicronized curcumin powderNative curcumin powder

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy volunteers with routine blood chemistry values within the normal ranges

You may not qualify if:

  • 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
  • participation in a clinical trial within the past 3 months prior to recruitment
  • known intolerance against curcuma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, 70599, Germany

Location

Related Publications (1)

  • Schiborr C, Kocher A, Behnam D, Jandasek J, Toelstede S, Frank J. The oral bioavailability of curcumin from micronized powder and liquid micelles is significantly increased in healthy humans and differs between sexes. Mol Nutr Food Res. 2014 Mar;58(3):516-27. doi: 10.1002/mnfr.201300724. Epub 2014 Jan 9.

    PMID: 24402825RESULT

Related Links

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Jan Frank, Ph.D.

    University of Hohenheim, Stuttgart, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2013

First Posted

August 19, 2013

Study Start

October 1, 2011

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

DE(1)