Effects of consumption of the test food on fatigue

Not Applicable

• Conditions: Healthy Japanese

• Registration Number: JPRN-UMIN000052671
• Lead Sponsor: ORTHOMEDICO Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Study Completion: 2024-03-17
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

Exclusion Criteria

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 any of the following chronic diseases: cardiovascular disease, cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. are undergoing medical treatment or have a medical history of chronic fatigue syndrome 5. have been diagnosed with psychiatric disorder and are undergoing treatment 6. have score of the Center for Epidemiologic Studies Depression Scale is 16 or more 7. are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 8. are taking medications, "Foods for Specified Health Uses," "Foods with Functional Claims," or supplements which may affect fatigue or sleep 9. are taking medications (including herbal medicines) and supplements 10. are allergic to medicines and/or the test food related products 11. are pregnant, lactating, or planning to become pregnant during this study 12. have menoxenia (women only) 13. have bleeding teeth or oral problems (gingivitis, dry mouth, stomatitis, etc.) 14. have undergone or plan to undergo dental, or oral treatment {treatment of dental decay, periodontal disease, or others, including periodic scaling (dental cleaning)} within one month prior to the screening (before consumption) and during this study 15. answered "have smoked cigarettes daily or occasionally within the last month" among those who have habitually smoked cigarettes in the past 16. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study 17. are judged as ineligible to participate in this study by the physician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. The measured values of total score in the Chalder Fatigue Scale (CFS) and subjective fatigue measured by visual analogue scale (VAS) at eight weeks after consumption (8w)