Influence of Selenium on Prostate Cancer Related Biomarkers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Influence of Selenium on Prostate Cancer Related Biomarkers

Conditions
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Effect of Selenium on Oxidative Stress in Healthy Men

Intervention / Treatment
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* Other: Placebo
* Dietary Supplement: selenomethionine
* Dietary Supplement: low dose selenized-yeast
* Dietary Supplement: high dose selenized-yeast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose selenized-yeast<br>200 µg/day of selenized-yeast (SY) | Dietary Supplement: low dose selenized-yeast<br>* 200 µg/day of SY<br>* Other names: SY;|
| Experimental: selenomethionine<br>The second group will receive 200 µg/day of selenomethionine (SM) | Dietary Supplement: selenomethionine<br>* 200 µg/day of selenomethionine (SM)<br>* Other names: SM;|
| Placebo Comparator: Placebo<br>no active medication. | Other: Placebo<br>* no active medication<br>|
| Experimental: High dose selenized-yeast<br>The fourth group will receive 285 µg/day of selenized-yeast (SY). | Dietary Supplement: high dose selenized-yeast<br>* 285 µg/day of SY<br>* Other names: SY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of oxidative stress |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma levels of selenium and selenium metabolites |  | 12 months | 
| PSA |  | 12 months | 
| Plasma Glucose |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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selenium, oxidative stress, prostate cancer, PSA, glucose