Study to confirm the effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre) on improving sleep quality.
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000051361
- Lead Sponsor
- Medical Corporation Hokubukai Utsukushigaoka Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 100
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sleep quality as measured by SLEEP SCOPE (SleepWell Co., Osaka, Japan)
- Secondary Outcome Measures
Name Time Method 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)