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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Doberer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00895167
First received: May 6, 2009
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Dietary Supplement: curcumin
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) in Healthy Male Subjects

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

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 ]

Enrollment: 12
Study Start Date: January 2009
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: curcumin
every subject receives 12 g of oral curcumin
Dietary Supplement: curcumin
one oral dose of 12 caplets = 12 g curcumin
Other Names:
  • Curcumin C3 Complex caplets containing:
  • 1000 mg curcumin and 5 mg bioperine
  • Lot. Nr.: #BA 08072227

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895167

Locations
Austria
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090
Sponsors and Collaborators
Daniel Doberer
  More Information

Additional Information:
No publications provided

Responsible Party: Daniel Doberer, Subinvestigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00895167     History of Changes
Other Study ID Numbers: EudraCT - 2008-004900-30
Study First Received: May 6, 2009
Last Updated: January 16, 2013
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Heme Oxygenase
Genetic Polymorphism
Healthy Subjects

Additional relevant MeSH terms:
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014