Healthy Japanese
Conditions
Interventions
Duration: Four weeks Test food: Powdered food 1
Duration: Four weeks Test food: Powdered food 2
Duration: Four weeks Test food: Placebo food
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. Individuals aged 30 or more and less than 60 4. Healthy individuals 5. Individuals who are judged as eligible to participate in the study by the physician according to the results of the Beck depression inventory (BDI-II) at screening 6. Individuals whose Total Mood Disturbance (TMD) score in the Profile of Mood States 2nd Edition (POMS2) is high among those who meet inclusion criteria No.1~5 without meeting any of exclusion criteria
Exclusion criteria
Exclusion criteria: Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. 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. are currently undergoing medical treatment or have a medical history of insomnia or sleep disorder 5. are currently undergoing medical treatment or have a medical history of psychiatric disorder such as depression disorder 6. are currently undergoing medical treatment or have a medical history of chronic fatigue syndrome 7. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 8. are taking medications, "Foods for Specified Health Uses," "Foods with Functional Claims," or supplements which may affect fatigue or sleep 9. are taking medications (including herbal medicines) and supplements 10. are allergic to medicines and/or the test food related products 11. are pregnant, lactating, or planning to become pregnant during this study 12. sleep with more than one person 13. have irregular sleeping time or habit due to work such as a late-night shift 14. need to get up in the middle of the night for childcare or nursing care 15. have irregular lifestyles (such as not working full-time, not eating meals at regular intervals, or not sleeping enough) 16. usually drink to excess (average of more than about 20 g/day as absolute alcohol intake) 17. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 18. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of Total Mood Disturbance (TMD), Tension-Anxiety (TA), Depression-Dejection (DD), Anger-Hostility (AH), Vigor-Activity (VA), Fatigue-Inertia (FI), Confusion-Bewilderment (CB), and Friendliness (F) in the Profile of Mood States 2nd Edition (POMS2) at four weeks after consumption (4w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Each item in the POMS2 at 4w 2. "Sleepiness on rising", "Initiation and maintenance of sleep", "frequent dreaming", "refreshing", "sleep length", and each item in the OSA sleep inventory MA version (OSA-MA) at 4w 3. Total score in the Athens Insomnia Scale (AIS) at 4w 4. Each item in the AIS at 4w 5. The measured values of salivary cortisol at 4w 6. The gut microbiota, intestinal metabolites, blood metabolites, and blood hormone at 4w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed