None listed
Conditions
Interventions
Food Containing Plant Extract, 8 weeks consumption.
Placebo Products, 8 weeks consumption.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Healthy Japanese males and females aged 20 to 79 years-old. 2)Subjects whose BMI are under 30. 3)Subjects who tend to feel frequent urination. 4)Subjects who are not suspected of having overactive bladder in the OABSS score, and/or having benign prostatic hyperplasia in the IPSS score at screening. 5)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: Subjects(who) 1)are currently undergoing or have been deemed to require treatment for urinary disorders, and/or taking or have taken medication related to urinary function. 2)have a history of and/or contract serious diseases (e.g., liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease and/or metabolic disease). 3)contract sleep apnea syndrome. 4)are under treatment for or have a history of drug addiction and/or alcoholism. 5)have a history and/or a surgical history of digestive disease affecting digestion and absorption. 6)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) during study periods. 7)have declared allergic reaction to foods. 8)can't stop drinking from 2 days before each measurement. 9)have alcohol intake more than approximately 20 g/day of pure alcohol equivalent or a habit of drinking not less than 4 days a week. 10)are shiftworker and/or midnight-shift worker. 11)live with people requiring long-term care. 12) sleep with a spouse, children, or pets and do not sleep alone in the same bed. 13)are judged as unsuitable for the current study by the investigator based on clinical testing during screening. 14)have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 15)are pregnant or planning to become pregnant or breastfeed during the study period. 16)are participating in or willing to participate in other clinical studies. 17)are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OAB-q score after 8 weeks of intake. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other related indexes after 8 weeks of intake. | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed