Healthy Japanese subjects
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 40 or more 4. Healthy subjects 5. The average number of daily steps is 8000 or more per day in the last one week including the time of the agreement to participate in this trial or the average number of daily steps is 5000 or less per day in the last one week including the time of the agreement to participate in this trial 6. The bottom 52 subjects with low muscle mass among those who meet inclusion criteria No.1~5 without meeting any of exclusion criteria
Exclusion criteria
Exclusion criteria: 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 diseases: 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" 5. Subjects who are taking medications (including herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, lactating, or planning to become pregnant during this 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 are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The walking speed at 12 weeks after consumption (12w) 2. The muscle mass at 12w | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Walking time, number of steps, stride length, walking rate (the number of steps per time), grip strength, body weight, body mass index, body fat percentage, fat mass, lean body mass, and body water at 12w | — |
Countries
Japan
Contacts
ORTHOMEDICO Inc. R&D Department