Healthy Japanese subjects
Conditions
Interventions
Duration: Eight weeks Take one active food with water before breakfast once daily *If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day a
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged between 40 and 64 4. Healthy subjects 5. Subjects whose frequency of urination is eight or more in the daytime 6. Subjects whose frequency of urination is two or more in the nighttime 7. Subjects whose score of urinary urgency of the Overactive Bladder Symptom Score (OABSS) is less than two or total score of OABSS is less than three at screening (before consumption: Scr) 8. Subjects whose total score of OABSS is five or less at Scr 9. Subjects whose score of the International Prostate Symptom Score (IPSS) is seven or less
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are currently undergoing treatment for any of the following chronic diseases: urination disorder, sleep disorder, cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or particularly urination-related health food on a daily basis 5. Subjects who 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)} 6. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift 7. Subjects whose sleeping and waking time are irregular and whose sleeping hours is five or less 8. Subjects who sleep with more than one person 9. Subjects who take health food or nutritional supplement with anti-oxidative capacity 10. Subjects who are currently taking medications (including herbal medicines) and supplements 11. Subjects who are allergic to medicines and/or the test food related products 12. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 13. Subjects who suffer from COVID-19 14. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 15. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The overactive bladder questionnaire (OAB-q) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Pittsburgh Sleep Quality Index (PSQI), the Core Lower Urinary Tract Symptom Score (CLSS), and the Nocturia Quality of Life questionnaire (N-QOL) 2. 8-hydroxy-2'-deoxyguanosine (8-OHdG) level in the urine and the blood levels of diacron-reactive oxygen metabolites (d-ROM), biological anti-oxidant potential (BAP), dihydrotestosterone (DHT), testosterone, lipid hydroperoxide (LPO), and blood pressure 3. The average frequency of urination in the daytime, in the nighttime, and during the day, and the urination amount on rising | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed