Healthy Japanese
Conditions
Interventions
Duration: 12 weeks Test product: Supplement containing elastin peptides derived from horse Administration: Consume two capsules per day after lunch and before sleep
Duration: 12 weeks Test product:
Sponsors
BIOCON (JAPAN) LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Men or women 3. Adults (aged >= 40 and < 75 years) 4. Healthy individuals 5. Individuals who are judged in the Kellgren-Lawrence grade (KL grade) as 0 or 1 in X-ray at screening (Scr) 6. Individuals whose score of the JKOM measured by Visual Analogue Scale: (VAS) is high at Scr
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 horse-derived substances 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 usually use "Foods for Specified Health Uses," or "Foods with Functional Claims" {e.g. N-acetylglucosamine, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide} 10. Individuals who engage in intense, knee 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 may use them during this study 12. Individuals who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The measured values of the score of Japanese Knee Osteoarthritis Measure (JKOM) {visual analog scale (VAS)} at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The measured values of the score of JKOM (VAS) at 6 weeks after consumption (6w) 2. The measured values of total score, "Pain and stiffness in knees" score, "Conditions in daily life" score, "General activities" score, and "Health conditions" score of the JKOM at 6w and 12w 3. Individuals whose responses to each item in the JKOM improved by one or more scales at 6w and 12w 4. The measured values of the Japanese Orthopaedic Association (JOA) score (left/right averaged, left leg, and right leg), pain on walking (left/right averaged, left leg, and right leg), pain on ascending or descending stairs (left/right averaged, left leg, and right leg), range of motion (left/right averaged, left leg, and right leg), joint swelling (left/right averaged, left leg, and right leg), high-sensitivity C-reactive protein at 12w 5. Individuals whose JOA score improved by one or more scales at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed