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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Daniel Doberer, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT00895167

First received: May 6, 2009

Last updated: January 16, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	May 6, 2009
Last Updated Date	January 16, 2013
Start Date ^ICMJE	January 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 7, 2009)	The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00895167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 7, 2009)	Increase of plasma bilirubin level [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects
Official Title ^ICMJE	The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Healthy
Intervention ^ICMJE	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
Study Arm (s)	Experimental: curcumin every subject receives 12 g of oral curcumin Intervention: Dietary Supplement: curcumin
Publications *	Not Provided
* 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
Enrollment ^ICMJE	12
Completion Date	August 2009
Primary Completion Date	July 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Male
Ages	18 Years to 45 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Austria

Administrative Information
NCT Number ^ICMJE	NCT00895167
Other Study ID Numbers ^ICMJE	EudraCT - 2008-004900-30
Has Data Monitoring Committee	No
Responsible Party	Daniel Doberer, Medical University of Vienna
Study Sponsor ^ICMJE	Daniel Doberer
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Medical University of Vienna
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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