Healthy
Conditions
Interventions
Capsules containing freeze-dried L. reuteri ATCC PTA 6475 powder, formulated to provide 5x10^9 CFU per capsule. Participants will take 8 capsules per day.
Capsules manufactured by replacing the freeze
Sponsors
Hiroshima University
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1) Healthy male 2) Willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Individuals who regularly take medication for chronic diseases 2) Individuals suspected of having a disease at the time of the screening test 3) Individuals who experience early morning erections less than once per week on average 4) Individuals with a total AMS score indicating severe symptoms (50 points or higher) 5) Individuals who regularly take supplements (including foods) that may affect sex hormone levels or gut microbiota 6) Individuals currently undergoing treatment for, or with a history of, erectile dysfunction (ED) or benign prostatic hyperplasia 7) Individuals with a history of mental disorders such as depression or attention-deficit/hyperactivity disorder (ADHD) 8) Individuals participating in another clinical study at the time of this study or who have participated in another clinical study within the past three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (week 0) over 12 weeks in the Heinemann Aging Males' Symptoms (AMS) score | — |
Secondary
| Measure | Time frame |
|---|---|
| 12-week changes in serum testosterone levels (total and free), estradiol levels, SF-36 (Medical Outcome Study 36-Item Short-Form Health Survey; a questionnaire for assessing health-related quality of life), muscle mass, and fecal microbiota. | — |
Countries
Japan
Contacts
Public ContactMasafumi Noda
Graduate School of Biomedical and Health Scie nces, Hiroshima University Department of Probiotic Science for Preventive Medicine
Outcome results
None listed