Effects of consumption of the test food on subjective fatigue in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000048301
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 128
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. 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 currently taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects whose sleeping time or habit is irregular due to working a late-night shift 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who suffer from COVID-19 10. 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 11. 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 1. Subjective fatigue at pre-workload after eight-week consumption (8w)
- Secondary Outcome Measures
Name Time Method 1. The change in subjective fatigue between pre and post-workload after 8w 2. Subjective fatigue at pre-workload after four-week consumption (4w) 3. The change in subjective fatigue between pre and post-workload at 4w 4. Each score of Profile of Mood States 2nd Edition (POMS2) and the OSA sleep inventory MA version (OSA-MA) at 4w and 8w 5. Each item of POMS2 and OSA-MA at 4w and 8w 6. Salivary amylase activity at 4w and 8w