Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Active capsule Administration: Take four capsules per day with water without chewing *If you forget to take the test food, take it as soon as you remember. Daily dos
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. Subjects aged 30 or more and less than 70 4. Healthy subjects 5. Subjects who usually feel tired or stress easily 6. Subjects whose TMD score in the POMS2 is relatively high among those who agreed to participate in the study
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 5. Subjects who are currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 8. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues 10. Subjects whose sleeping time or habit is irregular due to work such as a late-night shift 11. Subjects who have irregular lifestyles (such as diet, exercise, and sleep) 12. Subjects who are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 13. Subjects who work in physical labor such as transportation of heavy objects 14. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Profile of Mood States 2nd Edition (POMS2) | — |
Secondary
| Measure | Time frame |
|---|---|
| The MOS Short-Form 36-Item Health Survey version 2 (SF-36v2), fatigue measured by visual analogue scale (VAS), 8-hydroxy-2'-deoxyguanosine (8-OHdG) level in the urine, salivary cortisol, diacron-reactive oxygen metabolites (d-ROMs), biological anti-oxidant potential (BAP) | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed