Healthy Japanese
Conditions
Interventions
Duration: Eight weeks Test food: Active food Administration: Take one serving per day.
Duration: Eight weeks Test food: Placebo food Administration: Take one serving per day.
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 20 or more and less than 50 4. Healthy individuals 5. Individuals whose total score in the CFS is 16 or more
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 3. are currently undergoing treatment for any of the following chronic diseases: cardiovascular disease, cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are undergoing medical treatment or have a medical history of chronic fatigue syndrome 5. have been diagnosed with psychiatric disorder and are undergoing treatment 6. have score of the Center for Epidemiologic Studies Depression Scale is 16 or more 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. have menoxenia (women only) 13. have bleeding teeth or oral problems (gingivitis, dry mouth, stomatitis, etc.) 14. have undergone or plan to undergo dental, or oral treatment {treatment of dental decay, periodontal disease, or others, including periodic scaling (dental cleaning)} within one month prior to the screening (before consumption) and during this study 15. answered "have smoked cigarettes daily or occasionally within the last month" among those who have habitually smoked cigarettes in the past 16. 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 17. are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured values of total score in the Chalder Fatigue Scale (CFS) and subjective fatigue measured by visual analogue scale (VAS) at eight weeks after consumption (8w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of total score in the CFS and subjective fatigue measured by VAS at four weeks after consumption (4w) 2. The changes from screening (before consumption) of total score in the CFS and subjective fatigue measured by VAS at 4w and 8w 3. The changes from 4w of total score in the CFS and subjective fatigue measured by VAS at 8w 4. The measured values of physical fatigue score, mental fatigue score in the CFS, "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), and total score in the Athens Insomnia Scale (AIS) at 4w and 8w 5. The measured values of total score in the Japanese version of the Center for Epidemiologic Studies Depression Scale (CES-D), 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 Japanese version of the Profile of Mood States 2nd Edition (POMS2), flicker value (average of both eyes), high frequency (HF), low frequency (LF), LF/HF ratio, Total Power, glutathione peroxidase activity, superoxide dismutase (SOD) activity, diacron-reactive oxygen metabolites (d-ROMs), biological antioxidant potential (BAP), BAP/d-ROMs ratio, lipid peroxide, blood antioxidant capacity analysis by the multiple free-radical scavenging (MULTIS) method, urinary 8-hydroxy-2'-deoxyguanosine (8-OHdG), urinary homovanillic acid, urinary vanillylmandelic acid, salivary cortisol, salivary secretory immunoglobulin A (s-IgA), and each item in the original questionnaire about facial skin at 8w 6. Each item in the POMS2 at 8w 7. Each item in the AIS and each item in the CFS at 4w and 8w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed