Healthy adult
Conditions
Interventions
Intake of test supplement for 8 consecutive weeks
Intake of placebo for 8 consecutive weeks
Sponsors
FANCL Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese female from 20 to 80 years of age 2. Subjects who have problems with urinary voiding (urinary frequency more than 8 times during the day)
Exclusion criteria
Exclusion criteria: 1. Subjects who are judged to have overactive bladder 2. Subjects who have nocturia more than twice in the bladder diary at the time of the pre-test 3. Subjects who are undergoing hospitalization/treatment for dysuria, or those who have been judged to require treatments 4. Subjects who are unable to measure or record the urine volume for a designated period 5. Subjects who have urinary tract infection, urinary tract stones, kidney stones, ureteral stones, gallstones, etc. 6. Subjects who are taking health foods that affect urination at least once a week 7. Subjects who are currently taking medication or exercise therapy 8. Subjects who have or have a history diseases such as diabetes, hepatic, renal, cardiac diseases, diseases that affect the secretion of adrenal cortical hormones, or other metabolic diseases 9. Subjects who have a disease that requires constant medication, those who have a disease under treatment, those who have a history of serious disease that required medication 10. Subjects who may develop allergies in relation to the study 11. Subjects who have participated in other clinical trials within the past month prior to the pre-test date 12. Subjects who have had abnormalities in clinical test values or cardiopulmonary function, and are judged to have a problem participating in the study 13. Subjects whose physical measurements, physical examination values, and clinical test values before the start of intake were significantly out of the reference range 14. Subjects who work in shifts, work late at night, etc., and have an irregular daily rhythm 15. Subjects who are judged to be unsuitable as subjects based on the answers to the background survey. 16. Subjects who plan to become pregnant or breastfeed during the study period 17. Subjects who are judged to be unsuitable as subjects by the principal investigator or the principle investigational doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bladder diary (urinary frequency, urine volume) | — |
Secondary
| Measure | Time frame |
|---|---|
| OAB-q, OABSS-Bother, IPSS-Bother, Pittsburgh sleep quality index-Japanese version (PSQI-J) Subgroup analysis of primary and secondary outcome based on urinary frequency, nocturia, or PSQI-J | — |
Countries
Japan
Contacts
Public ContactBansho Yoshimi
EP Mediate Co., Ltd. R&D Support Center Foods Department Trial Planning Section 1
Outcome results
None listed