Effects of consumption of the test food on psychological stress
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000044398
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 66
Not provided
1. Subjects who are undergoing medical treatment or have at least one previous medical history of malignant tumor, heart failure, myocardial infarction, mental disorder, immunodeficiency, short bowel syndrome, ulcerative colitis, valvular heart disease or bowel obstruction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects who are currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 4. Subjects who take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily use 5. Subjects who currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, or planning to become pregnant during the 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 irregular sleeping hours and habits due to night shifts, etc. 10. Subjects who are smokers 11. Subjects who have infant children 12. Subjects who are judged as ineligible to participate in the study by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Profile of Mood States 2nd Edition (POMS2) Japanese version
- Secondary Outcome Measures
Name Time Method 1. Visual analogue scale (VAS) 2. Test of autonomic nervous system 3. Saliva test 4. Oguri-Shirakawa-Azumi sleep inventory version MA (OSA-MA)