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

NCT ID: NCT00895167

Last Updated: 2013-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-08-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

curcumin

every subject receives 12 g of oral curcumin

Group Type: EXPERIMENTAL

curcumin

Intervention Type: DIETARY_SUPPLEMENT

one oral dose of 12 caplets = 12 g curcumin

Interventions

curcumin

one oral dose of 12 caplets = 12 g curcumin

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Curcumin C3 Complex caplets containing: 1000 mg curcumin and 5 mg bioperine; Lot. Nr.: #BA 08072227

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Daniel Doberer

OTHER

Sponsor Role: lead

Responsible Party

Daniel Doberer

Subinvestigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, , Austria

Countries

Austria

Related Links

http://www.meduniwien.ac.at/klpharm/

Department of Clinical Pharmacology of the Medical University of Vienna

Other Identifiers

EudraCT - 2008-004900-30

Identifier Type: -

Identifier Source: org_study_id