Effect of Probiotics on Testosterone in Men

Healthy Clinical Trial

Official title:

A Double-blind Randomized Clinical Study Investigating Lactobacillus Reuteri Supplementations Influence on Testosterone Levels in Healthy Men

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04577625
• Other study ID #: CSUB0176
• Status: Completed
• Phase: N/A
• Start date: November 5, 2020
• Est. completion date: June 5, 2021

Study information

• Verified date: September 2020
• Source: BioGaia AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the effect of L. reuteri ATCC PTA 6475 supplementation on testosterone in men.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Lactobacillus reuteri (L. reuteri)
L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only

Locations

Country	Name	City	State
Sweden	Department of Health & Society, Malmö University	Malmö	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
BioGaia AB

Country where clinical trial is conducted

Sweden, 

Outcome

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