None listed
Conditions
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.
Interventions
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 P
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.
Sponsors
Professor Graeme Young MD, FRACP
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
Yes
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),
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.
Outcome results
None listed