Effect of Curcumin on Iron Metabolism in Healthy Volunteer

Phase 2

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: curcuma longa

• Registration Number: NCT01489592
• Lead Sponsor: Institut National de la Santé Et de la Recherche Médicale, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-10
• Study First Submitted: 2011-12-08
• Study First Submitted QC: 2011-12-08
• Study First Posted: 2011-12-09
• Study Completion: 2012-03
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-10
• Last Update Posted: 2013-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
curcumin	curcuma longa	oral administration of 6g of curcumin
placebo	curcuma longa	oral administration of 12 sugar pill

Primary Outcome Measures

Name	Time	Method
Maximal variation of serum hepcidin level after oral administration of curcumin	within 48 hours after administration of curcumin

Secondary Outcome Measures

Name	Time	Method
Plasmatic iron bioavailability	30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H	Iron, ferritin, transferrin, transferrin saturation
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.

Trial Locations

Locations (1)

Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou; 🇫🇷 Rennes, France