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Report for Clinical Trial NCT01489592

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Effect of Curcumin on Iron Metabolism in Healthy Volunteer

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.

NCT01489592 Healthy Volunteers

1 Interventions

Name: curcuma longa

Description: oral administration of 6 grams of curcumin

Type: Drug

curcumin placebo


Primary Outcomes

Measure: Maximal variation of serum hepcidin level after oral administration of curcumin

Time: within 48 hours after administration of curcumin

Secondary Outcomes

Description: Iron, ferritin, transferrin, transferrin saturation

Measure: Plasmatic iron bioavailability

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

Description: 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.

Measure: Evaluation of the inhibitory activity of volunteers's serum on hepcidin expression by hepatocytes

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

Purpose: Basic Science

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 C282Y

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.. 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. --- C282Y ---

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. --- C282Y ---



HPO Nodes