Effect of Curcumin on Iron Metabolism in Healthy Volunteer

Healthy Volunteers Clinical Trial

— CURHEP  

Official title:

Effect of Curcumin on Iron Metabolism in Healthy Volunteer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489592
• Other study ID #: C11-14
• Secondary ID: 2011-001925-26
• Status: Completed
• Phase: Phase 2
• First received: December 8, 2011
• Last updated: April 10, 2013
• Start date: October 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Exclusion period on the healthy volunteer National File.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• curcuma longa
oral administration of 6 grams of curcumin

Locations

Country	Name	City	State
France	Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Fatih N, Camberlein E, Island ML, Corlu A, Abgueguen E, Détivaud L, Leroyer P, Brissot P, Loréal 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. — View Citation

Loréal 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Aug 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal variation of serum hepcidin level after oral administration of curcumin		within 48 hours after administration of curcumin	No
Secondary	Plasmatic iron bioavailability	Iron, ferritin, transferrin, transferrin saturation	30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H	No
Secondary	Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes	In vitro: the coculture model that we previously developed to analyze endogenous hepcidin expression, and; human hepatic cells line (HepG2) stimulated or not by IL-6 which governs the STAT3 pathway, transfected with gene reporter constructs containing hepcidin promoter.	30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h	No