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 64 at the time of obtaining consent to participate in the study (2) Subjects with BMI between 18.5 and 30.0 at the screening test (3) Subjects who experience stress in daily life (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 with intention to improve fatigue, stress or sleep who receive any treatments (including hospital visits or medical treatment) or who use any pharmaceuticals or health foods. (6) Subjects who have been diagnosed with chronic fatigue syndrome (7) Subjects who are under psychiatric consultation or have history of psychiatric consultation for mental disorders (depression, etc.) or sleep disorders (8) Subject who take beverage containing large amount of caffeine (400 mg/day or more) in daily base (9) Subjects who take foods or supplements containing lactobacilli or bifidobacteria 3 times or more a week (Suguki pickle, bran pickle, kimchi, "Labre capsules", etc.) (10) Shift workers including late-night shifts, or subjects who have extremely irregular eating, sleeping, or other lifestyle habits (11) Subjects who drink more than 60 g pure alcohol equivalent/day on average (12) Smokers (13) Subjects who are expected to undergo a major change in family or work environment or other stressful situation (e.g., job change, moving, marriage) from one month prior to the screening test to the end of this study. (14) Subjects who exercise heavily in daily base (15) Subjects who donated blood within 3 months at screening (16) Subjects who are participating in clinical research or monitoring (food, pharmaceuticals, cosmetics) other than this research, or plan to participate during this research period (17) Subjects who are judged to be inappropriate for this study with other reasons by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in salivary chromogranin A, Total Mood Disturbance (TMD: overall mood disorder degree) as measured by the Japanese short version of the Profile of Mood States 2nd Edition (POMS 2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in salivary Cortisol and s-IgA, Visual Analogue Scale of stress and tiredness, Change in PSQI | — |
Countries
Japan
Contacts
Public ContactTakuya Matsuda
Medical Corporation Hokubukai Utsukushigaoka Hospital Clinical Pharmacology Center
Outcome results
None listed