NCT01489592

Brief Summary

The purpose of this study is to determine the impact of curcumin, administrated orally, on iron metabolism in healthy volunteers. Iron metabolism will be describe by hepcidin expression that the investigators observed in vitro and serum hepcidin levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2 healthy-volunteers

Timeline
Completed

Started Oct 2011

Shorter than P25 for phase_2 healthy-volunteers

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
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

August 27, 2025

Status Verified

April 1, 2013

Enrollment Period

Same day

First QC Date

December 8, 2011

Last Update Submit

August 26, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Maximal variation of serum hepcidin level after oral administration of curcumin

    within 48 hours after administration of curcumin

Secondary Outcomes (2)

  • Plasmatic iron bioavailability

    30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H

  • Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes

    30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

Study Arms (2)

curcumin

EXPERIMENTAL

oral administration of 6g of curcumin

Drug: curcuma longa

placebo

PLACEBO COMPARATOR

oral administration of 12 sugar pill

Drug: curcuma longa

Interventions

curcuma longaDRUG

oral administration of 6 grams of curcumin

curcuminplacebo

Eligibility Criteria

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

You may qualify if:

  • Body mass index between 18 et 25 Kg/m²
  • Non smoker
  • No swallowing disorders
  • Normal clinical exam
  • Normal ECG
  • Normal values for routine biological tests : serum iron, transferrin saturation,, hemogram ferritin, C Reactive Protein, AST, ALT, HDL and LDL cholesterol, triglycerides
  • No C282Y mutation within the HFE gene
  • Affiliation to social security
  • Written informed consent obtained

You may not qualify if:

  • Chronic or evolutive disease
  • Infection during the 7 days before each sequence
  • Drug or alcohol (\>30g) abuse
  • Current treatment
  • Known food allergy
  • stay at altitude (\> 1500m) in 2 months
  • Positive serology for hepatitis B or C virus or HIV.
  • Transfusion or blood donation during the last three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou

Rennes, 35000, France

Location

Related Publications (6)

  • Laine F, Laviolle B, Bardou-Jacquet E, Fatih N, Jezequel C, Collet N, Ropert M, Morcet J, Hamon C, Reymann JM, Loreal O. Curcuma decreases serum hepcidin levels in healthy volunteers: a placebo-controlled, randomized, double-blind, cross-over study. Fundam Clin Pharmacol. 2017 Oct;31(5):567-573. doi: 10.1111/fcp.12288. Epub 2017 May 7.

    PMID: 28370178BACKGROUND

  • Fatih N, Camberlein E, Island ML, Corlu A, Abgueguen E, Detivaud L, Leroyer P, Brissot P, Loreal O. Natural and synthetic STAT3 inhibitors reduce hepcidin expression in differentiated mouse hepatocytes expressing the active phosphorylated STAT3 form. J Mol Med (Berl). 2010 May;88(5):477-86. doi: 10.1007/s00109-009-0588-3. Epub 2010 Feb 19.

    PMID: 20169331BACKGROUND

  • Loreal O, Haziza-Pigeon C, Troadec MB, Detivaud L, Turlin B, Courselaud B, Ilyin G, Brissot P. Hepcidin in iron metabolism. Curr Protein Pept Sci. 2005 Jun;6(3):279-91. doi: 10.2174/1389203054065392.

    PMID: 15974953BACKGROUND

  • Verga Falzacappa MV, Vujic Spasic M, Kessler R, Stolte J, Hentze MW, Muckenthaler MU. STAT3 mediates hepatic hepcidin expression and its inflammatory stimulation. Blood. 2007 Jan 1;109(1):353-8. doi: 10.1182/blood-2006-07-033969. Epub 2006 Aug 31.

    PMID: 16946298BACKGROUND

  • Sharma RA, Euden SA, Platton SL, Cooke DN, Shafayat A, Hewitt HR, Marczylo TH, Morgan B, Hemingway D, Plummer SM, Pirmohamed M, Gescher AJ, Steward WP. Phase I clinical trial of oral curcumin: biomarkers of systemic activity and compliance. Clin Cancer Res. 2004 Oct 15;10(20):6847-54. doi: 10.1158/1078-0432.CCR-04-0744.

    PMID: 15501961BACKGROUND

  • Vareed SK, Kakarala M, Ruffin MT, Crowell JA, Normolle DP, Djuric Z, Brenner DE. Pharmacokinetics of curcumin conjugate metabolites in healthy human subjects. Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1411-7. doi: 10.1158/1055-9965.EPI-07-2693.

    PMID: 18559556BACKGROUND

MeSH Terms

Interventions

turmeric extract

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2011

First Posted

December 9, 2011

Study Start

October 1, 2011

Primary Completion

October 1, 2011

Study Completion

March 1, 2012

Last Updated

August 27, 2025

Record last verified: 2013-04

Locations

FR(1)