The Effects of Oral Curcumin on Heme Oxygenase-1 (HO-1) i... | NCT00895167

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

NCT00895167

Sponsor

Daniel Doberer

Status

Completed

Last Update Posted

Jan 17, 2013Estimated

Enrollment

12Actual

Phase

Phase 1

Conditions

Healthy

Interventions

curcumin

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Jul 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

May 6, 2009

First Submission Date that Met QC Criteria

May 7, 2009

First Posted Date

May 8, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 16, 2013

Last Update Posted Date

Jan 17, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Label	Type	Description	Intervention Names
curcumin	Experimental	every subject receives 12 g of oral curcumin	Dietary Supplement: curcumin

Name	Type	Description	Arm Group Labels	Other Names
curcumin	Dietary Supplement	one oral dose of 12 caplets = 12 g curcumin	curcumin

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

Measure	Description	Time Frame
Increase of plasma bilirubin level		48 hrs

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D036381	Diarylheptanoids
D006536	Heptanes
D000473	Alkanes
D006839	Hydrocarbons, Acyclic