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

Daniel Doberer

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Dietary Supplement: curcumin

Study type

Interventional

Funder types

Other

Identifiers

NCT00895167

EudraCT - 2008-004900-30

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.