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

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ClinicalTrials.gov Identifier: NCT01489592
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Tracking Information
First Submitted Date  ICMJE December 8, 2011
First Posted Date  ICMJE December 9, 2011
Last Update Posted Date April 11, 2013
Study Start Date  ICMJE October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2011)
Maximal variation of serum hepcidin level after oral administration of curcumin [ Time Frame: within 48 hours after administration of curcumin ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01489592 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2011)
  • Plasmatic iron bioavailability [ Time Frame: 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 [ 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Official Title  ICMJE Effect of Curcumin on Iron Metabolism in Healthy Volunteer
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: curcuma longa
oral administration of 6 grams of curcumin
Study Arms  ICMJE
  • Experimental: curcumin
    oral administration of 6g of curcumin
    Intervention: Drug: curcuma longa
  • Placebo Comparator: placebo
    oral administration of 12 sugar pill
    Intervention: Drug: curcuma longa
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 8, 2011)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01489592
Other Study ID Numbers  ICMJE C11-14
2011-001925-26 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor  ICMJE Institut National de la Santé Et de la Recherche Médicale, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institut National de la Santé Et de la Recherche Médicale, France
Verification Date April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP