Effect of Probiotics on Testosterone in Men
A Double-blind Randomized Clinical Study Investigating Lactobacillus Reuteri Supplementations Influence on Testosterone Levels in Healthy Men
1 other identifier
interventional
60
1 country
1
Brief Summary
This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Nov 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedStudy Start
First participant enrolled
November 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2021
CompletedJune 21, 2021
September 1, 2020
7 months
September 30, 2020
June 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Concentration of total testosterone
Change in total testosterone concentration over time
Baseline, 6 weeks, 12 weeks
Secondary Outcomes (3)
Free testosterone index
Baseline, 6 weeks, 12 weeks
Percentage of hematokrit
Baseline, 6 weeks, 12 weeks
Number of adverse events
Continously 12 weeks
Study Arms (3)
L. reuteri Low Dose
ACTIVE COMPARATORL. reuteri will be delivered in a capsule at a low dose including Vitamin D3. Administration twice daily.
L. reuteri High Dose
ACTIVE COMPARATORL. reuteri will be delivered in a capsule at a high dose including Vitamin D3. Administration twice daily.
Placebo
PLACEBO COMPARATORThe 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.
Interventions
L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioGaia ABlead
Study Sites (1)
Department of Health & Society, Malmö University
Malmo, Skåne County, 205 06, Sweden
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2020
First Posted
October 8, 2020
Study Start
November 5, 2020
Primary Completion
June 5, 2021
Study Completion
June 5, 2021
Last Updated
June 21, 2021
Record last verified: 2020-09