The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects (CUMAHS)

Study Description

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Brief Summary:

Heme oxygenase 1 (HO-1) serves as a protective gene. Induction of HO-1 has therapeutic potential for several indications. The inducibility of HO-1 by curcumin will be evaluated in this pilot study. Furthermore, the influence of a modulating factor of HO-1 gene activity on the dinucleotide guanosine thymine repeat (GT) length polymorphism in the promotor region will be investigated.

Condition or disease	Intervention/treatment	Phase
Healthy	Dietary Supplement: curcumin	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects
Study Start Date :	January 2009
Actual Primary Completion Date :	July 2009
Actual Study Completion Date :	August 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: curcumin; every subject receives 12 g of oral curcumin	Dietary Supplement: curcumin; one oral dose of 12 caplets = 12 g curcumin; Other Names: Curcumin C3 Complex caplets containing:; 1000 mg curcumin and 5 mg bioperine; Lot. Nr.: #BA 08072227

Outcome Measures

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Primary Outcome Measures :

1. The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs [ Time Frame: 48 hrs ]

Secondary Outcome Measures :

1. Increase of plasma bilirubin level [ Time Frame: 48 hrs ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Signed informed consent prior to any study-mandated procedure.
• Male patient aged between 18 and 45 years (inclusive) at screening.
• No clinically significant findings on the physical examination at screening.
• Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
• 12-lead ECG without clinically relevant abnormalities at screening.
• Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
• Negative results from urine drug screen at screening.
• Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

• Known hypersensitivity to the study drug or any excipients of the drug formulation.
• Treatment with another investigational drug within 3 weeks prior to screening.
• History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
• History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
• Smoking within the last 3 months prior to screening.
• Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
• Regularly intake of curcumin rich food
• Loss of 250 ml or more of blood within 3 months prior to screening.
• Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
• Positive results from the HIV serology at screening.
• Presumed non-compliance.
• Legal incapacity or limited legal capacity at screening.

Contacts and Locations

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Locations

Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090

Sponsors and Collaborators

Daniel Doberer

More Information

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Additional Information:

Department of Clinical Pharmacology of the Medical University of Vienna 

Responsible Party:	Daniel Doberer, Subinvestigator, Medical University of Vienna
ClinicalTrials.gov Identifier:	NCT00895167 History of Changes
Other Study ID Numbers:	EudraCT - 2008-004900-30
First Posted:	May 8, 2009
Last Update Posted:	January 17, 2013
Last Verified:	January 2013

Keywords provided by Daniel Doberer, Medical University of Vienna:

Heme Oxygenase; Genetic Polymorphism; Healthy Subjects

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