Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test food: Food containing plant-origin nano-sized lactic acid bacterium SNK (Lactiplantibacillus plantarum strain SNK12) Administration: Take one packet per day with water.
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who are dissatisfied with their subjective fatigue upon waking and sleep quality (such as short sleep time, difficulty falling asleep, difficulty sleeping soundly, dreaming, and persistent fatigue) in daily life 6. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck Depression Inventory 2nd Edition (BDI-II) at screening (before consumption; Scr) 7. Individuals whose Zc score of "sleepiness on rising" in the OSA-MA were low at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Individuals who are undergoing treatment for immunodeficiency disease 5. Individuals who are undergoing treatment for heart valve disease 6. Individuals who are undergoing treatment for sleep disorder 7. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 8. Individuals who are taking or using medications (including herbal medicines) and supplements 9. Individuals who are allergic to medicines or foods related to test products 10. Individuals whose sleeping habits are irregular due to night shifts and other lifestyle reasons 11. Individuals who sleep with more than one person 12. Individuals who live with requiring long-term care persons or their infants 13. Individuals who are pregnant, lactating, or planning to become pregnant during this study 14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 15. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of "sleepiness on rising" in the OSA sleep inventory MA version (OSA-MA) at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of "initiation and maintenance of sleep," "frequent dreaming," "refreshing," and "sleep length" in the OSA-MA at 4w 2. The measured values of blood cortisol, blood serotonin, blood chromogranin A, blood tumor necrosis factor (TNF)-alfa, blood interleukin (IL)-6, salivary cortisol, salivary chromogranin A, salivary secretory immunoglobulin A (sIgA), and salivary amylase at 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed