Healthy Japanese
Conditions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men 3. Individuals aged 40 or more 4. Healthy individuals 5. Individuals whose blood concentration of total testosterone is 250 ng/dL or more at screening (before consumption; Scr) 6. Individuals whose blood concentration of free testosterone is 7.5 pg/mL or more at Scr 7. Individuals whose total score in aging males symptoms (AMS) is less than 50 and relatively high 8. Individuals who are suffering from erectile dysfunction, decreased libido, delayed ejaculation, or decreased semen volume
Exclusion criteria
Exclusion criteria: Individuals (who/whose) 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are currently undergoing treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes, dyslipidemia, hypertension, autoimmune disease, hemorrhagic disease, benign prostatic hyperplasia, or other chronic diseases 4. have treatment histories of the following diseases within last one year: male menopause, sleep apnea syndrome, erectile dysfunction 5. use "Foods for Specified Health Uses," or "Foods with Functional Claims" 6. are currently taking medications (including herbal medicines) and supplements 7. are allergic to medicines and/or the test food related products 8. have participated in other clinical studies within the last 28 days before agreeing to participate in this study or plan to participate another study during this study 9. are currently taking, or have taken in the past month, any foods/supplements that may affect male function (e.g., foods rich in ingredients with suggested effects similar to the test product (Pycnogenol, zinc, Korea ginseng, maca extract, coenzyme Q10) 10. have mental health issues (e.g., depression disorder, attention deficit/hyperactivity disorder) 11. total AMS score is >=50 (severe) 12. International Index of Erectile Function score is 10~15 (severe) 13. sleeping time or habit is irregular due to work such as a late-night shift or three shifts 14. are smokers or have quit smoking within 3 months before agreeing to participate 15. usually drink more than 60 g/day of alcohol 16. may undergo surgery (including tooth extraction, endoscopic examination, or others) during the study or within 4 weeks after the end of consumption 17. are judged as ineligible to participate in this study by the physician 18. body mass index (BMI) is >=30 kg/m^2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Aging males symptoms (AMS) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of International Index of Erectile Function (IIEF) score, each question item of IIEF, Physical Component Summary (PCS), Mental Component Summary (MCS), Role-social Component Summary (RCS), Physical Functioning (PF), Role Physical (RP), Bodily Pain (BP), General Health (GH), Vitality (VT), Social Functioning (SF), Role Emotional (RE), Mental Health (MH), total testosterone, and free testosterone at 12w 2. Individuals who answered "no" to each question item of Androgen Deficiency in Aging Males (ADAM) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed