We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01489592
Recruitment Status : Completed
First Posted : December 9, 2011
Last Update Posted : April 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: curcuma longa Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Curcumin on Iron Metabolism in Healthy Volunteer
Study Start Date : October 2011
Primary Completion Date : October 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Maximal variation of serum hepcidin level after oral administration of curcumin [ Time Frame: within 48 hours after administration of curcumin ]

Secondary Outcome Measures :
  1. Plasmatic iron bioavailability [ Time Frame: 30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H ]
    Iron, ferritin, transferrin, transferrin saturation

  2. 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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01489592


Locations
France
Centre d'Investigation Clinique (CIC) , 2 rue Henri Le Guilloux , CHU Pontchaillou
Rennes, France, 35000
Sponsors and Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
More Information

Publications:
Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT01489592     History of Changes
Other Study ID Numbers: C11-14
2011-001925-26 ( EudraCT Number )
First Posted: December 9, 2011    Key Record Dates
Last Update Posted: April 11, 2013
Last Verified: April 2013

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action