Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Capsule containing pumpkin seeds extract Administration: Take one capsule with water two times a day each after breakfast and dinner *If you forget to take the test
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Individuals aged 50 or more 4. Healthy individuals 5. Individuals who are concern about frequency of urination 6. Individuals who are judged as eligible to participate in the study by the physician 7. Individuals whose score of urinary urgency of overactive bladder symptom score (OABSS) are less than two or whose total score of OABSS are less than three at Scr 8. Individuals whose the measured values of HRQL total score of OAB-q is relatively low at Scr
Exclusion criteria
Exclusion criteria: Individuals who 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 (ICD) 3. 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. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products (particularly Cucurbitaceae plants) 7. have allergic or atopic diseases 8. are pregnant, lactating, or planning to become pregnant during this study 9. have been enrolled in other clinical studies within the last 28 days before the agreement to participate or plan to participate another study during this study 10. are judged as ineligible to participate in this study by the physician 11. are undergoing treatment, have had treatment within two months, or need the treatment for diseases related to urination, e.g. overactive bladder, underactive bladder, cystitis, interstitial cystitis, bladder cancer, bladder stones, urethritis, urethral stricture, neurological disease, polyuria, and nocturnal polyuria 12. wake up twice or more to urinate at bedtime 13. have overactive bladder symptom (individuals who urinate eight times or more per day, and have urinary urgency at least once a week) 14. 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)}
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of Health-Related Quality of Life (HRQL) total score of the overactive bladder questionnaire (OAB-q) at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of HRQL total score of the OAB-q at four and eight weeks after consumption (4w, 8w) 2. The measured values of symptom bother, coping, concern, sleep, and social interaction of the OAB-q at 4w, 8w, and 12w 3. The measured values of each item of the OAB-q at 4w, 8w, and 12w 4. The amount and rate of changes of HRQL total score, symptom bother, coping, concern, sleep, and social interaction between screening (before consumption; Scr) and 4w, 8w, or 12w 5. The measured values of the average frequency of urination in the daytime, in the nighttime, and all day in period 3~14, and the amount and rate of changes of each item from period 1 and period 2* *Period 1: For 7 days prior to Scr Period 2: For 7 days prior to initial consumption Period 3: For 7 days since initial consumption Period 4: 8~14 days after consumption Period 5: 15~21 days after consumption Period 6: 22~28 days after consumption Period 7: 29~35 days after consumption Period 8: 36~42 days after consumption Period 9: 43~49 days after consumption Period 10: 50~56 days after consumption Period 11: 57~63 days after consumption Period 12: 64~70 days after consumption Period 13: 71~77 days after consumption Period 14: From 78 days after consumption to the day before 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed