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This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men.
The probiotic Lactobacillus reuteri ATCC PTA 6475 has been shown to modulate testosterone levels in mice. It is not known if these effects are seen in humans and this trial is intended to study this.
The aim of this study is to investigate if L. reuteri ATCC PTA 6475 will effect blood testosterone levels in in healthy male subjects 50-65 years of age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L. reuteri Low Dose | Active Comparator | L. reuteri will be delivered in a capsule at a low dose including Vitamin D3. Administration twice daily. |
|
| L. reuteri High Dose | Active Comparator | L. reuteri will be delivered in a capsule at a high dose including Vitamin D3. Administration twice daily. |
|
| Placebo | Placebo Comparator | The placebo product will be identical to the active product in taste and appearance and include Vitamin D3 but without the L. reuteri. Administration twice daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri (L. reuteri) | Dietary Supplement | L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only |
|
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of total testosterone | Change in total testosterone concentration over time | Baseline, 6 weeks, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Free testosterone index | Change in Free testosterone index (100x(Testosterone/SHBG) over time | Baseline, 6 weeks, 12 weeks |
| Percentage of hematokrit | Change in Hematokrit over time |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Health & Society, Malmö University | Malmö | Skåne County | 205 06 | Sweden |
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| Baseline, 6 weeks, 12 weeks |
| Number of adverse events | Adverse event from administration of first dose until 12 weeks | Continously 12 weeks |