Healthy Japanese subjects
Conditions
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Subjects aged 50 or more 4. Healthy subjects 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects who don't meet any of the following conditions a. grip strength is less than 28 kg (males), or less than 18 kg (females) b. normal walking speed is less than 1 m/s 7. Subjects who have relatively low values of the muscle mass
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 who 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 take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 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 who are pregnant, lactation, or planning to become pregnant 8. Subjects who suffer from COVID-19 9. 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 10. Subjects who are undergoing or need to undergo treatment for knee or waist disease such as osteoarthritis 11. Subjects who have undergone or need to undergo knee or waist surgery 12. Subjects who may experience rheumatic pain 13. Subjects who are attending an orthopedic or osteopathic clinic 14. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The muscle mass at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| Walking time, number of steps, stride length, walking rate (the number of steps per time), the number of times of standing up from the chair for 30 seconds, grip strength, body weight, body mass index, body fat percentage, fat mass, lean body mass, muscle mass, and body water at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed