Effect of Curcumin on Iron Metabolism in Healthy Volunteer

Institut National de la Santé Et de la Recherche Médicale, France18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy Volunteers

Interventions

curcuma longaDRUG

oral administration of 6 grams of curcumin

Eligibility

Sex: MALEMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou

Rennes, France

Outcomes

Primary Outcomes

Maximal variation of serum hepcidin level after oral administration of curcumin

Time frame: within 48 hours after administration of curcumin

Secondary Outcomes

Plasmatic iron bioavailability

Iron, ferritin, transferrin, transferrin saturation

Time frame: 30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H

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.

Time frame: 30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

Data from ClinicalTrials.gov

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