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The potential of selenium supplements provided as selenium-enriched dairy protein or yeast selenium to improve selenium status

Phase 4
Completed
Conditions
Plasma selenium concentration Levels of biomarkers in rectal epithelium
Plasma selenium concentration
Levels of biomarkers in rectal epithelium
Diet and Nutrition - Other diet and nutrition disorders
Registration Number
ACTRN12607000345482
Lead Sponsor
Professor Graeme Young MD, FRACP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
20
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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
evel of plasma glutathione peroxidase (GSPx), plasma selenium concentration & plasma selenoprotein P[Taken at fortnightly intervals throughout the study ];Level of biomarkers in rectal epithelium including selected endpoints from selenium concentration and Glutathione Peroxidase (GSPx)[Taken at commencement & end of intervention (week 0 & week 6) & at end of 6wk follow on/wash out period]
Secondary Outcome Measures
NameTimeMethod
evel 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. [Taken at commencement & end of intervention (week 0 & week 6) & at end of 6wk follow on/wash out period];Level of biomarkers in blood taken, including plasma Se, GSPx & selenoprotein P.[At fortnightly intervals throughout the study.]
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