Healthy Japanese subjects
Conditions
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 subjects 5. Subjects who usually feel tired or stress easily 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects whose the difference in VAS for fatigue before and after workload are large positively
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 who currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 5. Subjects whose sleeping time or habit is irregular due to working a late-night shift 6. Subjects who have physical labor such as transportation of heavy objects 7. Subjects who take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 8. Subjects who currently taking medications (including herbal medicines) and supplements 9. Subjects who are allergic to medicines and/or the test food related products 10. Subjects who are pregnant, lactation, or planning to become pregnant 11. Subjects who suffer from COVID-19 12. 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 13. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The difference in fatigue measured by VAS (visual analogue scale) before and after workload at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The fatigue measured by VAS before workload at 12w 2. The fatigue measured by VAS after workload at 12w 3. The following items of the test of the autonomic nervous system at 12w (before and after workload and the difference of them): LF (low frequency), HF (how frequency), LF/HF ratio, average heart rate, maximum heart rate, minimum heart rate, TP (total power), ccvTP (coefficient of component variance TP), deviation value of autonomic function, and autonomic functional age 4. The d-ROMs (diacron reactive oxygen metabolites), BAP (biological antioxidant potential), d-ROMs/BAP ratio, and BAP/d-ROMs at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed