Trial registered on ANZCTR


Trial ID
ACTRN12605000310662
Ethics application status
Approved
Date submitted
1/09/2005
Date registered
6/09/2005
Date last updated
14/07/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study exploring the potential of selenium incorporated in dairy proteins to improve health and reduce the risk of colon cancer.
Scientific title
The potential of selenium supplements via enriched dairy foods to improve bowel health and reduce risk of colon cancer in humans
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bowel Cancer 398 0
Condition category
Condition code
Cancer 470 470 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim is to explore the potential of selenium incorporated in dairy proteins to improve bowel health and reduce the risk of colon cancer. Participants will include a special dairy product in their diet in which the dairy proteins have been naturally enriched with selenium.
High selenium=100 micrograms per day, Placebo =1.5 micrograms selenium per day, in Milk protein concentrate prepared as a powdered food drink. Each intervention is 8 weeks in length with a 2 week wash-out between each phase. Markers of the health value of selenium will then be examined in samples of blood and samples taken from the lining of the bowel wall. The duration of the intervention will be 2 weeks baseline+ 8 weeks for each treatment phase (16wks) and 2 weeks wash out between treatment phases.
Intervention code [1] 327 0
Prevention
Comparator / control treatment
Milk protein concentrate with no added Selenium
Control group
Placebo

Outcomes
Primary outcome [1] 532 0
Level of plasma glutathione peroxidase (GSPx) taken at the beginning and end of each intervention
Timepoint [1] 532 0
At the beginning and end of each treatment (Week 0 and week 8).
Secondary outcome [1] 1138 0
Level of biomarkers in rectal epithelium including Glutathione (GSH), Glutathione Peroxidase (GSPx), histological PCNA cell proliferation and apoptosis rates, p53 immunohistochemical staining.
Timepoint [1] 1138 0
Taken at the beginning and end of each intervention (Wk 0 & week 8).
Secondary outcome [2] 1139 0
Level of biomarkers in blood including plasma selenium and/or erythrocyte Se, GSH, selenoprotein P, plasma levels of thyroid hormones T3 and T4, ).
Timepoint [2] 1139 0
Taken at the beginning and end of each intervention (Wk 0 & week 8).

Eligibility
Key inclusion criteria
Participants will be healthy, with no active bowel disease, or a previous history of adenoma removal >6 months ago, with plasma selenium at or below 95ug/dL.
Minimum age
50 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any allergy or intolerance to milk/dairy products plasma Se above the 95th percentile of the current population (i.e. >95ug/dl), evidence of any active mucosal bowel disease, eg colitis, or of malabsorption, no evidence of any other active clinical disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation of crossover sequence was assigned by numbered containers. The sequence was not concealed as 1 of 2 different flavoured protein powders (Strawberry or Vanilla) were used for each treatment phase. The Selenium levels were double blind.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Trial coordinators allocated protein powders to volunteers by alternation in relation to their scheduling through the clinical facility, prior to study commencement
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint(s)
Bio-availability
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 528 0
Charities/Societies/Foundations
Name [1] 528 0
Geoffrey Gardiner Dairy Foundation
Address [1] 528 0
Lvl 5/ 84 William St Melbourne 3000
Country [1] 528 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
1 Flinders Drive,
Bedford Park South Australia 5042
Country
Australia
Secondary sponsor category [1] 429 0
None
Name [1] 429 0
no secondary sponsor
Address [1] 429 0
no secondary sponsor
Country [1] 429 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1529 0
Flinders Medical Centre
Ethics committee address [1] 1529 0
Bedford Park, SA 5042
Ethics committee country [1] 1529 0
Australia
Date submitted for ethics approval [1] 1529 0
Approval date [1] 1529 0
Ethics approval number [1] 1529 0

Summary
Brief summary
To explore the potential of selenium incorporated in dairy proteins to improve health and reduce the risk of colon cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35646 0
Address 35646 0
Country 35646 0
Phone 35646 0
Fax 35646 0
Email 35646 0
Contact person for public queries
Name 9516 0
Ms Jane Upton
Address 9516 0
Department of Gastroenterology
Flinders Medical Centre
Bedford Park SA 5042
Country 9516 0
Australia
Phone 9516 0
+61 8 82046071
Fax 9516 0
+61 8 82046330
Email 9516 0
jane.upton@fmc.sa.gov.au
Contact person for scientific queries
Name 444 0
Prof. Graeme Young
Address 444 0
Department of Medicine (Gastroenterology)
Flinders University
Flinders Medical Centre
Bedford Park SA 5042
Country 444 0
Australia
Phone 444 0
+61 8 82044964
Fax 444 0
+61 8 82043943
Email 444 0
graeme.young@flinders.edu.au