Effects of consumption of the test food on subjective fatigue in healthy Japanese subjects
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000049097
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
Subjects who / whose 1.are undergoing medical treatment or have a medical history of malignancy, heart failure, and myocardial infarction 2.anthropometric measurements, physical examination values, or laboratory values are D or above in the criteria category of the Japan Society of Ningen Dock 3.have a medical history of cardiopathy, a pacemaker, or an implantable cardioverter defibrillator 4.have treatment for chronic disease such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension 5.are going a psychiatric medical institute / meet the criteria for a major depressive episode 6.are going a hospital / receive treatment / take medicines or health food to improve sleep or stress 7.usually take "Foods for Specified Health Uses," or "Foods with Functional Claims" 8.have a disease with constant medication / have a medical history of malignancy with medication (except for remission) 9.usually take medicines (including herbal medicines) and supplements 10.habitually take an energy drink once weekly or more 11.are allergic to medicines and/or the test food related products 12.work in late-night / sleep between 6 and 10 AM and get up between 6 and 8 PM once weekly or more 13.work in physical labor 14.have hormonal treatment / are diagnosed with menopausal syndrome by a doctor 15.are diagnosed with arrhythmia by a doctor 16.smoke / stopped smoking within one year before screening 17.usually drink more than an appropriate amount (about 20 g/day as absolute alcohol) 18.are pregnant, lactating, or planning to become pregnant during this trial 19.suffer from COVID-19 / are a close contact person 20.have been enrolled in other clinical trials within the last 28 days before the agreement to participate or plan to participate another trial during this trial 21.are judged from the interview to have difficulty receiving prescribed examination or complying with the restrictions 22.are judged as ineligible by the physician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method