Study to confirm the anti-stress effect of continuous ingestion of foods containing Lactobacillus brevis subsp. coagulans (Labre).
- Conditions
- Healthy adults
- Registration Number
- JPRN-UMIN000051307
- 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
- 50
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 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change in salivary Cortisol and s-IgA, Visual Analogue Scale of stress and tiredness, Change in PSQI