Healthy adults
Conditions
Interventions
Test food: Food containing Labre
Sponsors
Medical Corporation Hokubukai Utsukushigaoka Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy Japanese males and females between 20 and 65 years of age, or Japanese males and females with constipation tendency (defecation frequency less than 4 times/week) (2) Subjects who can be available at the research site on the designated dates (3) 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 take foods or supplements containing lactobacilli or bifidobacteria 3 times or more a week (Suguki pickle, bran pickle, kimchi, "Labre capsules", etc.) (6) Shift workers, including late-night shifts (7) Subjects who drink more than 60 g pure alcohol equivalent/day on average (8) Subjects who smoke an average of 21 cigarettes or more per day (9) Subjects who donated blood within 3 months at screening (10) Subjects who are participating in clinical research or monitoring (food, pharmaceuticals, cosmetics) other than this research, or plan to participate during this research period (11) Subjects who are judged to be inappropriate for this study with other reasons by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of the values of physical test, hematological test, blood biochemistry test and urinalysis, and the number of adverse events | — |
Countries
Japan
Contacts
Public ContactTakuya Matsuda
Medical Corporation Hokubukai Utsukushigaoka Hospital Clinical Pharmacology Center
Outcome results
None listed