Healthy adults
Conditions
Interventions
Duration: 8 weeks Test product: Product containing Administration: Consume one tablet three times daily (breakfast, lunch, and dinner, in total three tablets a day) with water. *If a take is miss
Sponsors
Toyo Sugar Refining Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men 3. Individuals aged 40 or more and less than 60 4. Healthy individuals 5. Individuals who are concerned about infertility 6. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck Depression Inventory-II (BDI-II) at Scr 7. Individuals whose blood concentration of total testosterone is 250 ng/dL or more at Scr 8. Individuals whose blood concentration of free testosterone is 7.5 pg/mL or more at Scr 9. Individuals whose AMS score is between 27 and 49 at Scr 10. Individuals whose psychological factors of the AMS is bad at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction 2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator 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 undergoing treatment for ED 7. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims 8. Individuals who are taking or using medications (including herbal medicines) or supplements 9. Individuals who are allergic to medications or foods related to the test product, particularly those allergic to citrus fruit 10. Individuals who regularly take long hot baths or use saunas 11. Individuals who are excessive exercising or training for diet 12. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles 13. Individuals who currently smoke or began smoking cessation within three months before providing informed consent 14. Individuals who habitually drink >= 60 g/day of alcohol 15. Individuals who are taking supplements containing zinc, folic acid, arginine, etc. 16. Individuals who are deemed unsuitable for participation in this study by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of Aging Males' Symptoms (AMS) score at 8 weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of progressive motility rate, sperm concentration, non-progressive motility rate, immotile rate, motile sperm concentration, progressive motile sperm concentration, normal morphology rate, Sperm Motility Index (SMI), total sperm count per ejaculation, motile sperm count per ejaculation, erectile rigidity, duration of erection, satisfaction with ejaculation, interest in women, frequency of morning erections, frequency of erections, psychological factors, physical factors, sexual function factors at 8w 2. Individuals whose response to the AMS improved by one or more scales at 8w compared to screening (Scr) 3. The measured value of free testosterone and testosterone at 8w 4. Individuals who experienced adverse events | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed