None listed
Conditions
Interventions
Sponsors
TOYO SHINYAKU Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy Japanese males and females aged 20 to 79 years-old. 2) Subjects who tend to feel frequent urination and sleep trouble. 3) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: 1) Subjects who are currently attending hospital or have a current medical history of a disease that could affect the study. 2) Subjects who are suspected of having overactive bladder in the OABSS score. 3) Subjects who are suspected of having benign prostatic hyperplasia. 4) Subjects who have a history and/or a surgical history of digestive disease affecting digestion and absorption. 5) Subjects who regularly use medications affecting the study. 6) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting urination and/or sleep. 7) Subjects who are shiftworker, midnight worker and/or hard worker. 8) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism. 9) Subjects who are pregnant or planning to become pregnant or breastfeed during the study period. 10) Subjects who live with a person requiring nursing care, and/or who are raising an infant or child. 11) Subjects who are allergic to test foods. 12) Subjects who are participating or intend to participate in other clinical trials that may affect the study at the time of commencement of the study. 13) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Indexes on sleeping | — |
Countries
Japan
Contacts
Public ContactNobutaka Kusaba
TOYO SHINYAKU Co., Ltd. Clinical and analytical research center
Outcome results
None listed