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

May 6, 2009
January 16, 2013
January 2009
July 2009   (final data collection date for primary outcome measure)
The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00895167 on ClinicalTrials.gov Archive Site
Increase of plasma bilirubin level [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects
The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Healthy
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
Experimental: curcumin
every subject receives 12 g of oral curcumin
Intervention: Dietary Supplement: curcumin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
August 2009
July 2009   (final data collection date for primary outcome measure)

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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00895167
EudraCT - 2008-004900-30
No
Daniel Doberer, Medical University of Vienna
Daniel Doberer
Not Provided
Not Provided
Medical University of Vienna
January 2013

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