Effect of Curcumin on Iron Metabolism in Healthy Volunteer (CURHEP)

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

Status and phase: Completed; Phase 2

Conditions: Healthy Volunteers

Treatments: Drug: curcuma longa

Study type: Interventional

Funder types: Other

Identifiers

NCT01489592

2011-001925-26 (EudraCT Number)

C11-14

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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18 participants in 2 patient groups, including a placebo group

curcumin

Experimental group

Description:

oral administration of 6g of curcumin

Treatment:

Drug: curcuma longa

placebo

Placebo Comparator group

Description:

oral administration of 12 sugar pill

Treatment:

Drug: curcuma longa