A verification study for improving on the fatigue with consumption of test food
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000037120
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 22
Not provided
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. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, gastrointestinal disorder, or any other chronic diseases 4. Subjects who are diagnosed with eosinophilia 5. Subjects who have the medical history or under the treatment of Shiitake dermatitis 6. Subjects who are diagnosed with photosensitivity 7. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage in daily 8. Subjects who are 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 smokers 11. Subjects who are pregnant, lactation, or planning to become pregnant 12. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to enroll in anther clinical trial during trial period 13. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Questionnaire of fatigue (established by Japanese Society of Fatigue Science)
- Secondary Outcome Measures
Name Time Method 1. MOS Short-Form 36-Item Health. Survey (SF-36) 2. Scoring of immunological vigor 3. T lymphocyte age 4. Immunological age 5. Lymphocyte subset 6. Salivary immunoglobulin A (sIgA) 7. Profile of Mood States 2nd Edition (POMS2) Japanese version