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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: curcumin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curcumin<br>every subject receives 12 g of oral curcumin | Dietary Supplement: curcumin<br>* one oral dose of 12 caplets = 12 g curcumin<br>* Other names: Lot. Nr.: #BA 08072227;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs |  | 48 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase of plasma bilirubin level |  | 48 hrs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heme Oxygenase, Genetic Polymorphism, Healthy Subjects