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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 July 28, 2015
Anti-Inflammatory Agents, Non-Steroidal
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sensory System Agents