Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test product: Sterone power mix HC2 (Hard capsule containing black currant extract, red perilla extract, and inositol mixture) Administration: Take two capsules per day at any t
Sponsors
JAPAN PHARMA Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men 3. Individuals aged 45 or more and less than 75 4. Healthy individuals 5. Individuals whose AMS score is between 27 and 49 6. Individuals whose BMI is 23 kg/m2 or more and less than 30 kg/m2 7. Individuals whose blood concentration of total testosterone is 2.5 ng/mL or more at screening 8. Individuals whose blood concentration of free testosterone is 7.5 pg/mL or more at screening
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction, hepatitis B, or hepatitis C 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 taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who usually take foods that may affect male menopause and sexual function, such as garlic, L-arginine, zinc, or maca 7. Individuals who are allergic to medicines or foods related to the test product 8. 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 9. Individuals who have treatment histories of diabetes mellitus, erectile dysfunction, benign prostatic hyperplasia, gastric ulcer, psychosis, dysgeusia, or anemia within last one year 10. Individuals who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 11. Individuals who usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) {500 mL: a medium bottle of beer or about 1.5 cans of canned chu-hi, 180 mL: 1 go of sake or about 1.5 glasses of wine, 90 mL: half-go with shochu, 60 mL: a glass of whiskey brandy (double)} 12. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Aging Males' Symptoms (AMS) at four weeks after intervention (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The MOS Short-Form 36-Item Health Survey (SF-36) at 4w 2. Total testosterone, free testosterone, luteinizing hormone, and follicle-stimulating hormone at 4w 3. Body weight, body mass index (BMI), body fat percentage, lean body mass, fat mass (whole body, right leg, left leg, right arm, left arm, and trunk), muscle mass (whole body, right leg, left leg, right arm, left arm, and trunk), systolic blood pressure, diastolic blood pressure, waist circumference, total cholesterol (T-Cho), high density lipoprotein-cholesterol (HDL-Cho), low density lipoprotein-cholesterol (LDL-Cho), triglyceride (TG), glucose (GLU), and hemoglobin A1c (HbA1c) at 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed