None listed
Conditions
Interventions
Food containing low-dose plant extract, 8 weeks consumption
Food containing high-dose plant extract, 8 weeks consumption
Food not containing plant extract, 8 weeks consumption
Sponsors
Clinical Creative 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 visiting the hospital or have a current diseases. 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 use habitually medications. 6)Subjects who can't stop using medications, supplements and/or functional foods affecting urination or sleeping during test periods. 7)Subjects who are shiftworker, midnight worker and/or hard worker. 8)Subjects who have excessive alcohol. 9)Subjects who are pregnant or planning to become pregnant or breastfeed during the study period. 10) Subjects who live with people requiring long-term care 11)Subjects who have declared allergic reaction to ingredients contained in test foods. 12) Subjects who are participating in or willing to participate in other clinical studies. 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 urination | — |
Secondary
| Measure | Time frame |
|---|---|
| Indexes on sleeping Questionnaire | — |
Countries
Japan
Contacts
Public ContactMasahiro Nakahara
Clinical Creative Co.,Ltd. Pharmaceutical Development Division
Outcome results
None listed