Healthy Japanese subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 20 or more and less than 60 4. Healthy subjects 5. Subjects who easily feel fatigue due to usual work 6. Subjects who are judged as eligible to participate in the study on the physician by result of Beck Depression Inventory-II (BDI2) at screening (before consumption; Scr) 7. Subjects who are judged as eligible to participate in the study by the physician
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 disease: 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, lactation, or planning to become pregnant 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 are judged as ineligible to participate in the study by the physician 10. Subjects whose working form are irregular (subjects whose number of working days vary every week, and who do not have a series of at least three days per week) 11. Subjects whose ifestyles are irregula (whose habits vary every day such as dietary habits, exercise habits, and sleeping habits) 12. Subjects who drink to excess (average of more than about 20 g/day as absolute alcohol intake) 13. Subjects who are undergoing medical treatment or have a medical history of chronic fatigue syndrome 14. Subjects who take food containing functional ingredients which may influence fatigue or stress in daily
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective evaluation of fatigue | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department