Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000345482
Ethics application status
Approved
Date submitted
26/06/2007
Date registered
26/06/2007
Date last updated
14/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The potential of selenium supplements provided as selenium-enriched dairy protein or yeast selenium to improve selenium status
Scientific title
The potential of selenium supplements provided as selenium-enriched dairy protein or yeast selenium to improve selenium status
Universal Trial Number (UTN)
Trial acronym
nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plasma selenium concentration
Levels of biomarkers in rectal epithelium 1896 0
Condition category
Condition code
Diet and Nutrition 1991 1991 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
It is proposed to evaluate a selenised dairy product (Tatura Bio Se®, TMI Victoria) in a human intervention study with regard to its safety and influence on selenium status, using plasma and rectal biomarkers.
A group of >50 year old volunteers considered at-risk for colon cancer by virtue of age and/or other standard risk factors.
Particpants will commence with a wash out period of 2-4 wks instructing them not to add selenium products to their diet
10 participants will be allocated Se Milk Protein Concentrate 150µg/d and a different group of 10 will be allocated Selplex 150µg/d at the same time i.e to run in parallel
Each participant will undertake a follow on wash out period of 6 weeks.
Blood samples will be taken every 2 weeks throughout the intervention and wash out periods
Rectal pinch biopsies will be performed for bowel tissue samples at the beginning and end of each intervention and at the end of the follow-on washout period.
Intervention code [1] 1852 0
Prevention
Comparator / control treatment
It will be compared for its efficacy and bioavailability with a selenium yeast (Sel-plex ?,Alltech) product.
Control group
Active

Outcomes
Primary outcome [1] 2813 0
Level of plasma glutathione peroxidase (GSPx), plasma selenium concentration & plasma selenoprotein P
Timepoint [1] 2813 0
Taken at fortnightly intervals throughout the study
Primary outcome [2] 2814 0
Level of biomarkers in rectal epithelium including selected endpoints from selenium concentration and Glutathione Peroxidase (GSPx)
Timepoint [2] 2814 0
Taken at commencement & end of intervention (week 0 & week 6) & at end of 6wk follow on/wash out period
Secondary outcome [1] 4739 0
Level of biomarkers in rectal epithelium. They include selenium concentration and thioredoxin reductase and glutathione peroxidase activities, and histologically: PCNA cell proliferation and apoptosis rates, and p53 immunohistochemical staining.
Timepoint [1] 4739 0
Taken at commencement & end of intervention (week 0 & week 6) & at end of 6wk follow on/wash out period
Secondary outcome [2] 4740 0
Level of biomarkers in blood taken, including plasma Se, GSPx & selenoprotein P.
Timepoint [2] 4740 0
At fortnightly intervals throughout the study.

Eligibility
Key inclusion criteria
Healthy, with no active bowel disease, orWith a previous history of adenoma removal >6 months ago, With plasma selenium at or below 100 µg/dL. (to ensure that people with a High background selenium status are not included in the study),
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any allergy or intolerance to milk/dairy productsPlasma Se above the 95th percentile of the current population (i.e. >100µg/dL)Evidence of any active mucosal bowel disease, eg colitis, or of malabsorption.With no evidence of any other active clinical disease precluding participation in the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2132 0
Charities/Societies/Foundations
Name [1] 2132 0
Geoffrey Gardiner Dairy Foundation Ltd (GGDF)
Country [1] 2132 0
Australia
Primary sponsor type
Individual
Name
Professor Graeme Young MD, FRACP
Address
Department of Medicine (Gastroenterology)
Flinders University
Flinders Medical Centre
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 1938 0
Individual
Name [1] 1938 0
Professor Graeme McIntosh BVSc PhD,
Address [1] 1938 0
9A Serpentine Rd.,
Belair, South Australia 5052
Country [1] 1938 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3929 0
Flinders Medical Centre-Flinders Clinical Drug Trials Committee & Flinders Clinical Research & Ethics Committee
Ethics committee address [1] 3929 0
Bedford Park SA 5042
Ethics committee country [1] 3929 0
Australia
Date submitted for ethics approval [1] 3929 0
Approval date [1] 3929 0
24/09/2007
Ethics approval number [1] 3929 0
214/067

Summary
Brief summary
It is proposed to evaluate a selenised dairy product with regard to its safety and influence on selenium status, using plasma and rectal biomarkers. It will be compared for its efficacy & bioavailability with a selenium yeast product.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27666 0
Address 27666 0
Country 27666 0
Phone 27666 0
Fax 27666 0
Email 27666 0
Contact person for public queries
Name 11041 0
Ms Jane Upton RN
Address 11041 0
Department of Gastroenterology
Flinders Medical Centre
Bedford Park SA 5042
Country 11041 0
Australia
Phone 11041 0
+61 8 82046071
Fax 11041 0
+61 8 82046330
Email 11041 0
[email protected]
Contact person for scientific queries
Name 1969 0
Professor Graeme McIntosh BVSc PhD,
Address 1969 0
Department of Gastroenterology
Flinders Medical Centre,
Bedford Park, SA 5042
Country 1969 0
Australia
Phone 1969 0
+61 8 82044964
Fax 1969 0
+61 8 82043943
Email 1969 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.