JPRN-UMIN000051361CompletedUnknown
Study to confirm the effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre) on improving sleep quality. - Study to confirm the effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre) on improving sleep quality.
Medical Corporation Hokubukai Utsukushigaoka Hospital0 sites100 target enrollmentStarted: June 16, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 20years-old to 65years-old (—)
- Sex
- All
Inclusion Criteria
- Not provided
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.
Investigators
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