NCT01982734

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.

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 Nov 2012

Shorter than P25 for early_phase_1

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

November 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
Last Updated

October 25, 2016

Status Verified

October 1, 2016

Enrollment Period

5 months

First QC Date

November 5, 2013

Last Update Submit

October 24, 2016

Conditions

Pharmacokinetics of New Curcumin FormulationsSafety of New Curcumin Formulations

Keywords

bioavailabilitycurcuminpharmacokineticcurcuma longaage differencessex 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, 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, 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, 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, 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, 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, 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, 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, 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, 2, 4, 6, 8 and 24 h post-dose

Secondary Outcomes (11)

  • Serum aspartate transaminase activity [U/L]

    0, 4, 24h post-dose

  • Serum alanine transaminase activity [U/L]

    0, 4, 24h post-dose

  • Serum gamma-glutamyl transferase 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

  • +6 more secondary outcomes

Study Arms (4)

Native curcumin

ACTIVE COMPARATOR

80 mg curcumin as native powder

Dietary Supplement: curcumin

Native curcumin plus phytochemicals

EXPERIMENTAL

80 mg curcumin as native powder plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid and 40 mg xanthohumol

Dietary Supplement: curcumin

Curcumin micelles

EXPERIMENTAL

80 mg curcumin incorporated into liquid micelles

Dietary Supplement: curcumin

Curcumin micelles plus phytochemicals

EXPERIMENTAL

80 mg curcumin incorporated into liquid micelles plus 80 mg sesamin, 40 mg naringenin, 40 mg ferulic acid, 40 mg xanthohumol incorporated into micelles

Dietary Supplement: curcumin

Interventions

curcuminDIETARY_SUPPLEMENT

80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals

Curcumin micellesCurcumin micelles plus phytochemicalsNative curcuminNative curcumin plus phytochemicals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers with routine blood chemistry values within the normal ranges
  • Age: 18-35 years or \> 60 years

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hohenheim

Stuttgart, Baden-Wurttemberg, 70599, Germany

Location

Related Publications (1)

  • Kocher, A., Schiborr, C., Behnam, D., & Frank, J. (2015). The oral bioavailability of curcuminoids in healthy humans is markedly enhanced by micellar solubilisation but not further improved by simultaneous ingestion of sesamin, ferulic acid, naringenin and xanthohumol. J Funct Foods 14: 183-19.

    RESULT

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

November 5, 2013

First Posted

November 13, 2013

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

October 25, 2016

Record last verified: 2016-10

Locations

DE(1)