Healthy adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men 3. Individuals aged 30 or more and less than 60 4. Healthy individuals 5. Individuals who are concerned about infertility
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are diagnosed with azoospermia 5. Individuals who are diagnosed with erectile dysfunction (ED) 6. Individuals who are undergoing medical treatment for ED 7. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 8. Individuals who are taking or using medicines (including herbal medicines) or supplements 9. Individuals who are allergic to medicines or foods related to the test product, particularly to citrus fruits 10. Individuals who regularly take long hot baths or use saunas 11. Individuals who are excessive exercising or training for diet 12. Individuals who have irregular sleeping time or habit due to work such as a late-night shift or irregular lifestyles Individuals who are smokers or have quit smoking within the last three months before the agreement to participate in this study 14. Individuals who usually drink more than 60 g/day of alcohol 15. Individuals who are taking supplements containing zinc, folic acid, arginine, etc. 16. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 17. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of "PROGRESSIVE" in the SQA-iO at four weeks after intervention (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of "CONCENTRATION," "NON-PROGRESSIVE," "IMMOTILE," "MOTILE SPERM CONC.," "PROG. MOTILE SPERM CONC.," "NORMAL FORMS," "SPERM MOTILITY INDEX (SMI)," "SPERM," and "MOTILE SPERM" in the SQA-iO at 4w 2. The measured values of penile rigidity, duration of erection, satisfaction with ejaculation, interest in women, frequency of morning erections, and frequency of erections at 4w | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department