Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Test food
Duration: 12 weeks Test product: Placebo food
Sponsors
MYCARE Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults 4. Healthy individuals 5. Individuals who are classified as Grade 0 or 1 in the Kellgren-Lawrence classification (KL Grade) based on X-ray 6. Individuals with a mean VAS score >= 66 mm 7. Individuals with low "Conditions in daily life" score of the JKOM
Exclusion criteria
Exclusion criteria: 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or 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, or any other chronic diseases 4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. Individuals who are taking or using medications (including herbal medicines) or supplements 6. Individuals who are allergic to medicines or foods related to the test product, particularly those who are allergic to shrimp or crab 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 in another study during this study 9. Individuals who regularly consume "Foods for Specified Health Uses" or "Foods with Functional Claims" (e.g., N-acetylglucosamine, salmon nasal cartilage-derived proteoglycan or undenatured type II collagen, glucosamine hydrochloride, curcumin, skipjack-derived elastin peptide, or collagen peptides) 10. Individuals who engage in intense, joint-loading exercise (e.g., ball sports such as soccer, baseball, basketball, or jogging, running, skiing, or snowboarding) 11. Individuals who use a cane or joint support, or who may require their use during the study period 12. 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 "Conditions in daily life" score of the Japanese Knee Osteoarthritis Measure (JKOM) at 12 weeks after intervention (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of visual analogue scale (VAS), total score, "Pain and stiffness in knees" score, "General activities" score, and "Health conditions" score of the JKOM at 12w 2. Individuals whose responses to each item of the JKOM improved by at least one grade at 12w compared with screening | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed