The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects (CUMAHS)
This study has been completed.
Information provided by (Responsible Party):
Daniel Doberer, Medical University of Vienna
First received: May 6, 2009
Last updated: January 16, 2013
Last verified: January 2013
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.
Dietary Supplement: curcumin
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects
Primary Outcome Measures:
- The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Increase of plasma bilirubin level [ Time Frame: 48 hrs ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||July 2009 (Final data collection date for primary outcome measure)
every subject receives 12 g of oral curcumin
Dietary Supplement: curcumin
one oral dose of 12 caplets = 12 g curcumin
- Curcumin C3 Complex caplets containing:
- 1000 mg curcumin and 5 mg bioperine
- Lot. Nr.: #BA 08072227
|Ages Eligible for Study:
||18 Years to 45 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895167
|Medical University of Vienna, Department of Clinical Pharmacology
|Vienna, Austria, 1090 |
No publications provided
||Daniel Doberer, Subinvestigator, Medical University of Vienna
History of Changes
|Other Study ID Numbers:
||EudraCT - 2008-004900-30
|Study First Received:
||May 6, 2009
||January 16, 2013
||Austria: Agency for Health and Food Safety
Keywords provided by Medical University of Vienna:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 09, 2013
Anti-Inflammatory Agents, Non-Steroidal
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Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents