Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Food containing yeast extract Administration: Dissolve one packet with water and drink it right after waking up *If you forget to take the test food, take it as soon
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men 3. Adults 4. Subjects aged less than 75 5. Healthy subjects 6. Subjects whose BMI are 23 kg/m2 or more and less than 30 kg/m2 7. Subjects whose lean mass are low
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 have lactose intolerance 5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 6. Subjects currently taking medicines (include herbal medicines) and supplements 7. Subjects who are allergic to medications and/or the test-food-related products (particularly milk) 8. Subjects who are pregnant, breast-feeding, and planning to become pregnant 9. Subjects who suffer from COVID-19 10. Subjects who cannot perform the specified training 11. 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 12. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lean mass at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cross-sectional area of rectus abdominis muscle, cross-sectional area of abdominal oblique muscle, total cross-sectional area of rectus abdominis muscle and abdominal oblique muscle, grip strength (right hand, left hand, and both hands average), the number of times of standing up from the chair for 30 seconds, the number of times of raising upper body for 30 seconds, waist circumference, hip circumference, body weight, body mass index, body fat percentage, fat mass (right arm, left arm, right leg, left leg, and trunk (torso)), and muscle mass {right arm, left arm, right leg, left leg, and trunk (torso)} at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed