Healthy adults
Conditions
Sponsors
Medical Corporation Hokubukai Utsukushigaoka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Japanese men and women aged between 20 and less than 65 at the time of obtaining consent to participate in the study (2) Subjects with BMI between 18.5 and less than 30.0 at the screening test (3) Subjects with a score of 6 or higher of the Japanese version of Pittsburgh Sleep Questionnaire (PSQI-J) at the screening test (4) Subjects who can be available at the research site on the designated dates (5) Subjects who have received sufficient explanations about the purpose and content of this study, have the ability to consent, volunteer to participate in this study in writing with a good understanding.
Exclusion criteria
Exclusion criteria: (1) Subjects who have a history of heart, liver, kidney disease, organ damage, diabetes, or other serious diseases (2) Subjects who have a history of gastrointestinal surgery (excluding appendectomy) (3) Subjects who are currently receiving medical drug treatment (4) Subjects who are pregnant, wish to become pregnant during the study, or are breastfeeding (5) Subjects who receive treatment for sleep disorders such as insomnia or sleep apnea (6) Subjects who regularly take health functional foods, health foods, supplements, etc. that claim to improve sleep quality (7) Subjects who take foods or supplements containing lactobacilli or bifidobacteria 3 times or more a week (Suguki pickle, bran pickle, kimchi, "Labre capsules", etc.) (8) Shift workers, including late-night shifts (9) Subjects who drink more than 60 g pure alcohol equivalent/day on average (10) Subjects who smoke an average of 21 cigarettes or more per day (11) Subjects who donated blood within 3 months at screening (12) Subjects who are participating in clinical research or monitoring (food, pharmaceuticals, cosmetics) other than this research, or plan to participate during this research period (13) Subjects who are judged to be inappropriate for this study with other reasons by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality as measured by SLEEP SCOPE (SleepWell Co., Osaka, Japan) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in Score of Japanese version of the Pittsburgh Sleep Quality Index (PSQI-j) , OSA sleep inventory MA version (OSA-MA), and Japanese short version of the Profile of Mood States 2nd Edition (POMS 2) | — |
Countries
Japan
Contacts
Public ContactTakuya Matsuda
Medical Corporation Hokubukai Utsukushigaoka Hospital Clinical Pharmacology Center
Outcome results
None listed