Healthy Clinical Trial
Official title:
A Double-blind Randomized Clinical Study Investigating Lactobacillus Reuteri Supplementations Influence on Testosterone Levels in Healthy Men
NCT number | NCT04577625 |
Other study ID # | CSUB0176 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 5, 2020 |
Est. completion date | June 5, 2021 |
Verified date | September 2020 |
Source | BioGaia AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 5, 2021 |
Est. primary completion date | June 5, 2021 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 50 Years to 65 Years |
Eligibility | Inclusion Criteria: - Willing and able to give signed informed consent for participation in the study. - Healthy males aged between 50-65 with no known underlying medical conditions - Subjects who are capable of taking themselves to testing centre at 3 separate timepoints (Baseline, week 6 and week 12). - Subjects who are available to give fasting blood samples before 10am on day of blood sample collection - No history of androgen or testosterone supplementation within 6 months prior to study start. - Subjects who have not been taking antibiotics or probiotic supplements 4 weeks prior to study start 8. Able and willing to comply with the restirictions defined for the study period - Ability to understand and comply with the requirements of the study, as judged by the investigator physician Exclusion Criteria: - Subjects who presently have or have had cardiovascular issues in the past 2 years. - Subjects who have a Body Mass Index of < 18 or > 30 - Known elevated Prostate Specific Antigen levels. - History of prostate or testicular cancer. - Nicotine abuse - Alcohol abuse |
Country | Name | City | State |
---|---|---|---|
Sweden | Department of Health & Society, Malmö University | Malmö | Skåne |
Lead Sponsor | Collaborator |
---|---|
BioGaia AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of total testosterone | Change in total testosterone concentration over time | Baseline, 6 weeks, 12 weeks | |
Secondary | Free testosterone index | Change in Free testosterone index (100x(Testosterone/SHBG) over time | Baseline, 6 weeks, 12 weeks | |
Secondary | Percentage of hematokrit | Change in Hematokrit over time | Baseline, 6 weeks, 12 weeks | |
Secondary | Number of adverse events | Adverse event from administration of first dose until 12 weeks | Continously 12 weeks |
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