CURHEP: Effect of Curcumin on Iron Metabolism in Healthy Volunteer

• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT01489592
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 3.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: curcuma longa	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Effect of Curcumin on Iron Metabolism in Healthy Volunteer
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Oct 1, 2011
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: curcumin oral administration of 6g of curcumin	Drug: curcuma longa; oral administration of 6 grams of curcumin
Placebo Comparator: placebo oral administration of 12 sugar pill	Drug: curcuma longa; oral administration of 6 grams of curcumin

Outcome Measures

Primary Outcome Measures

1. Maximal variation of serum hepcidin level after oral administration of curcumin [within 48 hours after administration of curcumin]

Secondary Outcome Measures

1. Plasmatic iron bioavailability [30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H]

   Iron, ferritin, transferrin, transferrin saturation

2. Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes [30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou	Rennes		France	35000

Sponsors and Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
• ClinicalTrials.gov Identifier: NCT01489592
• Other Study ID Numbers: C11-14; 2011-001925-26
• First Posted: Dec 9, 2011
• Last Update Posted: Apr 11, 2013
• Last Verified: Apr 1, 2013

• Additional relevant MeSH terms: Turmeric extract

Study Results

No Results Posted as of Apr 11, 2013