Healthy Japanese subjects
Conditions
Interventions
Intake of test supplement 1 for 12 consecutive weeks
Intake of test supplement 2 for 12 consecutive weeks
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. Men or women 3. Subjects aged between 40 and 69 4. Healthy subjects 5. Subjects who feel knee discomfort (and/or pain) at rest or movement 6. Subjects whose both knees are judged in the Kellgren-Lawrence grade (KL grade) as either 0 or 1 in standing position X-ray at screening (before consumption: Scr)
Exclusion criteria
Exclusion criteria: Subjects (who/whose) 1.are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2.have pacemaker or an implantable cardioverter defibrillator 3.are undergoing medical treatment or have a medical history for chronic disease such as arrhythmia, hepatopathy, nephropathy, cerebrovascular disorder, rheumatism, diabetes, dyslipidemia, hypertension, or hyperuricemia 4.have undergone or need to undergo joint surgery 5.have undergone intra-articular injections (e.g. hyaluronic acid or steroid) within a year before the agreement to participate, or who need to undergo them during this trial 6.have a history of markedly abnormal in laboratory values or cardiopulmonary function 7.intensely exercise with excessive load on joints 8.have a medical history of diseases associated with bone or joint such as fracture, sprain, arthritis, or periarthritis within a year before the agreement to participate 9.use a cane or joint support, or may use them during this trial 10.laboratory or measured values markedly deviate from the reference values at Scr 11.are judged as ineligible to participate based on a background investigation 12.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} 13.currently taking medications (including herbal medicines) 14.are allergic to medicines or the test food related products 15.are pregnant or lactating / plan to become pregnant during this trial 16.have or are strongly suspected to have an infectious disease such as COVID-19 17.have been enrolled in other clinical trials within the last 28 days before the agreement to participate or plan to participate another trial during this trial 18.are judged as ineligible to participate by the principle investigational doctor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment items for knee joint pain or discomfort | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed