Effect of Curcumin on Iron Metabolism in Healthy Volunteer - Full Text View

Purpose

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	Intervention	Phase
Healthy Volunteers	Drug: curcuma longa	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Basic Science
Official Title:	Effect of Curcumin on Iron Metabolism in Healthy Volunteer

Resource links provided by NLM:

MedlinePlus related topics: Iron

Drug Information available for: Curcumin Curcuma domestica

U.S. FDA Resources

Further study details as provided by Institut National de la Santé Et de la Recherche Médicale, France:

Primary Outcome Measures:

Maximal variation of serum hepcidin level after oral administration of curcumin [ Time Frame: within 48 hours after administration of curcumin ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasmatic iron bioavailability [ Time Frame: 30min, 1H, 2H, 3H, 4H, 6H, 8H, 12H, 24H et 48H ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Enrollment:	18
Study Start Date:	October 2011
Study Completion Date:	March 2012
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Fatih N, Camberlein E, Island ML, Corlu A, Abgueguen E, Détivaud L, Leroyer P, Brissot P, Loréal O. Natural and synthetic STAT3 inhibitors reduce hepcidin expression in differentiated mouse hepatocytes expressing the active phosphorylated STAT3 form. J Mol Med (Berl). 2010 May;88(5):477-86. Epub 2010 Feb 19.

Loréal O, Haziza-Pigeon C, Troadec MB, Detivaud L, Turlin B, Courselaud B, Ilyin G, Brissot P. Hepcidin in iron metabolism. Curr Protein Pept Sci. 2005 Jun;6(3):279-91. Review.

Verga Falzacappa MV, Vujic Spasic M, Kessler R, Stolte J, Hentze MW, Muckenthaler MU. STAT3 mediates hepatic hepcidin expression and its inflammatory stimulation. Blood. 2007 Jan 1;109(1):353-8. Epub 2006 Aug 31.

Sharma RA, Euden SA, Platton SL, Cooke DN, Shafayat A, Hewitt HR, Marczylo TH, Morgan B, Hemingway D, Plummer SM, Pirmohamed M, Gescher AJ, Steward WP. Phase I clinical trial of oral curcumin: biomarkers of systemic activity and compliance. Clin Cancer Res. 2004 Oct 15;10(20):6847-54.

Vareed SK, Kakarala M, Ruffin MT, Crowell JA, Normolle DP, Djuric Z, Brenner DE. Pharmacokinetics of curcumin conjugate metabolites in healthy human subjects. Cancer Epidemiol Biomarkers Prev. 2008 Jun;17(6):1411-7.

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
Study First Received:	December 8, 2011
Last Updated:	April 10, 2013
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: The Commission nationale de l’informatique et des libertés

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
Pharmacologic Actions

Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013

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