COVID-19 studies are our top priority. For all other trials, there is a 4-week delay in processing a trial submitted to the ANZCTR and additional delays for updates of registered trials. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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)

Study type
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
Comparator / control treatment
Milk protein concentrate with no added Selenium
Control group

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).

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Type of endpoint(s)
Statistical methods / analysis

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

Funding & Sponsors
Funding source category [1] 528 0
Name [1] 528 0
Geoffrey Gardiner Dairy Foundation
Address [1] 528 0
Lvl 5/ 84 William St Melbourne 3000
Country [1] 528 0
Primary sponsor type
Flinders Medical Centre
1 Flinders Drive,
Bedford Park South Australia 5042
Secondary sponsor category [1] 429 0
Name [1] 429 0
no secondary sponsor
Address [1] 429 0
no secondary sponsor
Country [1] 429 0

Ethics approval
Ethics application status
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
Date submitted for ethics approval [1] 1529 0
Approval date [1] 1529 0
Ethics approval number [1] 1529 0

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

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
Phone 9516 0
+61 8 82046071
Fax 9516 0
+61 8 82046330
Email 9516 0
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
Phone 444 0
+61 8 82044964
Fax 444 0
+61 8 82043943
Email 444 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary