Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test food: Kirokureisenko Administration: Take one packet (approximately 2 g) with water twice a day, in the morning and evening *If you forget to take the test food, take it a
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. Healthy individuals 3. Men or women 4. Individuals aged 65 or more 5. Individuals who do not have an exercise habit or recognize they do not have an exercise habit 6. Individuals who are classified as prefrailty according to Japanese Cardiovascular Health Study criteria (J-CHS criteria) at screening (before consumption; Scr) 7. Individuals whose whole body muscle mass is a few at Scr
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, knee osteoarthritis, or any other chronic diseases 4. Individuals who take "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) and supplements 6. Individuals who are allergic to medicines and/or the test food related products (particularly gelatin, tobacco, peach, tomato, or nut) 7. Individuals who are pregnant, lactating, or planning to become pregnant during this study 8. Individuals who 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 9. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of whole-body muscle mass at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of whole-body muscle mass at 6 weeks after consumption (6w) 2. The measured values of walking time, walking speed, 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, muscle mass (except whole-body muscle mass), Total Mood Disturbance (TMD), Anger-Hostility (AH), Confusion-Bewilderment (CB), Depression-Dejection (DD), Fatigue-Inertia (FI), Tension-Anxiety (TA), Vigor-Activity (VA), Friendliness (F), Physical Component Summary (PCS) score, Mental Component Summary (MCS) score, Role-social Component Summary (RCS) score, Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health at 6w and 12w 3. Individuals who are classified as prefrailty at 6w and 12 w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed