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

April 10, 2013 updated by: Institut National de la Santé Et de la Recherche Médicale, France
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35000
        • Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: curcumin
oral administration of 6g of curcumin
Drug: curcuma longa
oral administration of 6 grams of curcumin
Placebo Comparator: placebo
oral administration of 12 sugar pill
Drug: curcuma longa
oral administration of 6 grams of curcumin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximal variation of serum hepcidin level after oral administration of curcumin
Time Frame: within 48 hours after administration of curcumin
within 48 hours after administration of curcumin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasmatic iron bioavailability
Time Frame: 30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H
Iron, ferritin, transferrin, transferrin saturation
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
Time Frame: 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.
30min, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

December 8, 2011

First Submitted That Met QC Criteria

December 8, 2011

First Posted (Estimate)

December 9, 2011

Study Record Updates

Last Update Posted (Estimate)

April 11, 2013

Last Update Submitted That Met QC Criteria

April 10, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C11-14
  • 2011-001925-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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