Healthy Japanese subjects
Conditions
Interventions
Duration: 24 weeks Test food: Tablet containing salmon nasal cartilage-derived proteoglycan Administration: Take one tablet after dinner with water * Daily dose should be taken within the day. If
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. Male or female aged 20 or more 3. Healthy subjects 4. Subjects who feel declining in their muscular strength 5. Subjects who are judged as eligible to participate in the study by the physician 6. Subjects who satisfy more than two conditions out of the following conditions will be excluded from this study 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 c. skeletal muscle mass is less than 7.0 kg/m2 (males), or less than 5.7 kg/m2 (females) 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 are diagnosed with sarcopenia 5. Subjects who take ""Foods for Specified Health Uses,"" ""Foods with Functional Claims,"" or other functional food/beverage in daily use 6. Subjects who currently taking medications (including herbal medicines) and supplements 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 10. Subjects who are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured value of the muscle mass at 24 weeks after consumption (24w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured value of the muscle mass at 12 weeks after consumption (12w) 1-2. The change of the muscle mass from screening (before consumption; Scr) to 12w and 24w. 2. The measured values and amounts of changes from Scr of the following items at 12w and 24w: grip strength, walking time, number of steps, stride length, walking rate (the number of steps per time), normal walking speed, maximum walking speed, Locomo 25 total score, visual analog scale (VAS) of Japan Low Back Pain Evaluation Questionnaire (JLEQ), JLEQ total score, body fat percentage, body fat mass, lean body mass, high sensitivity C-reactive protein (CRP), total procollagen type I N-terminal propeptide (P1NP), bone-specific alkaline phosphatase (BAP), the Japanese Orthopaedic Association (JOA) hip score (pain, range of motion, walking ability, and activities of daily living), JOA shoulder score (pain, function, range of motion, X-ray score, and joint stability score), JOA lumbar spine score (subjective symptoms score, objective symptoms score ,activities of daily living, and urinary bladder function) 3. The measured values of the scores of the questionnaire (each item of Locomo 25, JLEQ, JOA hip score, JOA shoulder score, and JOA lumbar spine score) at 12w and 24w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed