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

Healthy Clinical Trial

— CUMAHS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895167
• Other study ID #: EudraCT - 2008-004900-30
• Status: Completed
• Phase: Phase 1
• First received: May 6, 2009
• Last updated: January 16, 2013
• Start date: January 2009
• Est. completion date: August 2009

Study information

• Verified date: January 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• curcumin
one oral dose of 12 caplets = 12 g curcumin

Locations

Country	Name	City	State
Austria	Medical University of Vienna, Department of Clinical Pharmacology	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Doberer

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs		48 hrs	No
Secondary	Increase of plasma bilirubin level		48 hrs	No

External Links

•   Department of Clinical Pharmacology of the Medical University of Vienna