Effect of Selenium on Oxidative Stress in Healthy Men
Conditions
Keywords
selenium, oxidative stress, prostate cancer, PSA, glucose
Brief summary
Penn State Milton S. Hershey Medical Center researchers are trying to compare the effects of two different forms of selenium (selenium yeast and selenomethionine) on blood selenium levels and biomarkers of oxidative stress as primary endpoints. One in six men are at risk of getting prostate cancer in their lifetime. Participants will be asked to take over-the-counter selenium yeast supplements and selenomethionine or a placebo for nine out of twelve months.
Detailed description
We will conduct a double-blind, randomized, placebo-controlled clinical study of selenium supplementation in the form of L-selenomethionine (SM)(200 µg/day) and selenium-enriched yeast (SY) (200 µg/day and 285 µg/day) for 9 months; the 285 µg/day SY is selected to deliver an equivalent selenium as in 200 µg/day SM to healthy men. The variability of SM in SY that will be used here is less than 3% and it accounts for 70.5% of the SM content in SY. As primary endpoints, we will determine the effects of these two forms of selenium on plasma levels of selenium and its metabolites as well as biomarkers of oxidative stress at several time points. As a secondary endpoint, the effect of these two forms of selenium on plasma PSA levels will be examined.
Interventions
OTHERPlacebo
no active medication
DIETARY_SUPPLEMENTselenomethionine
200 µg/day of selenomethionine (SM)
DIETARY_SUPPLEMENTlow dose selenized-yeast
200 µg/day of SY
DIETARY_SUPPLEMENThigh dose selenized-yeast
285 µg/day of SY
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* No history or evidence of diabetes * Male between the ages of 20-79 * PSA levels ≤ 4.0 ng/mL * Not taking \>50 µg/day selenium as a dietary supplement including multi- vitamins * Non-smoker * No concurrently participating or have participated in any other clinical trial within at least 30 days of registration * Health male
Exclusion criteria
* Evidence of prostate cancer * Evidence of liver or kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarkers of oxidative stress | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Plasma levels of selenium and selenium metabolites | 12 months |
| PSA | 12 months |
| Plasma Glucose | 12 months |
Countries
United States
Outcome results
None listed