Clinical trial NCT01489592: Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Official title: Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy Volunteers
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2011-12-09
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximal variation of serum hepcidin level after oral administration of curcumin
timeFrame: within 48 hours after administration of curcumin
Secondary outcomes:
measure: Plasmatic iron bioavailability
timeFrame: 30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H
measure: Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes
timeFrame: 30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou
Study officials:
References:
citation: 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.
citation: 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.
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. doi: 10.1182/blood-2006-07-033969. Epub 2006 Aug 31.
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. doi: 10.1158/1078-0432.CCR-04-0744.
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.