Effects of consumption of the test food on fatigue and stress in healthy Japanese
- Conditions
- Healthy Japanese
- Registration Number
- JPRN-UMIN000053020
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 102
Not provided
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 cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. are taking medications (including herbal medicines) and supplements 6. are allergic to medicines and/or the test food related products (particularly pork or horses) 7. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues 8. have irregular sleeping time or habit due to work such as a late-night shift 9. have irregular lifestyles (such as diet, exercise, and sleep) 10. are undergoing medical treatment for chronic fatigue syndrome or menopausal syndrome 11. work in physical labor such as transportation of heavy objects 12. are undergoing treatment for premenstrual syndrome and/or premenstrual dysphoric disorder 13. are receiving counseling and/or psychotherapy 14. have undergone or are undergoing hormonal therapy 15. are usually taking food containing functional ingredients which may influence fatigue or stress (such as S-allyl cysteine, gamma-aminobutyric acid, lactic acid bacteria, reduced form of coenzyme Q10, paramylon derived from Euglena gracilis, docosahexaenoic acid, eicosapentaenoic acid, astaxanthin, citric acid, L-theanine, polyphenol derived from black soybean, 5-aminolevulinic acid phosphate, or anserine) 16. are pregnant, lactating, or planning to become pregnant during this study 17. have been enrolled in other clinical studies within 28 days before the agreeing to participate or plan to participate another study during this study 18. are judged as ineligible to participate by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The measured value of Total Mood Disturbance (TMD) score in the Profile of Mood States 2nd Edition (POMS2) at 12 weeks after consumption (12w) (Intervention 1 vs Intervention 3)
- Secondary Outcome Measures
Name Time Method