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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose selenized-yeast | Experimental | 200 µg/day of selenized-yeast (SY) |
|
| selenomethionine | Experimental | The second group will receive 200 µg/day of selenomethionine (SM) |
|
| Placebo | Placebo Comparator | no active medication. |
|
| High dose selenized-yeast | Experimental | The fourth group will receive 285 µg/day of selenized-yeast (SY). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | no active medication |
| |
| selenomethionine |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers of oxidative stress | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma levels of selenium and selenium metabolites | 12 months | |
| PSA | 12 months | |
| Plasma Glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karam El-Bayoumy, PhD | Penn State College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Milton Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24938534 | Derived | Richie JP Jr, Das A, Calcagnotto AM, Sinha R, Neidig W, Liao J, Lengerich EJ, Berg A, Hartman TJ, Ciccarella A, Baker A, Kaag MG, Goodin S, DiPaola RS, El-Bayoumy K. Comparative effects of two different forms of selenium on oxidative stress biomarkers in healthy men: a randomized clinical trial. Cancer Prev Res (Phila). 2014 Aug;7(8):796-804. doi: 10.1158/1940-6207.CAPR-14-0042. Epub 2014 Jun 17. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D012645 | Selenomethionine |
| ID | Term |
|---|---|
| D016566 | Organoselenium Compounds |
| D009930 | Organic Chemicals |
| D008715 | Methionine |
| D000603 | Amino Acids, Sulfur |
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| Dietary Supplement |
200 µg/day of selenomethionine (SM) |
|
|
| low dose selenized-yeast | Dietary Supplement | 200 µg/day of SY |
|
|
| high dose selenized-yeast | Dietary Supplement | 285 µg/day of SY |
|
|
| 12 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D013457 |
| Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |