Healthy Japanese subjects
Conditions
Interventions
Duration: 12 weeks Test food: Food containing shark cartilage extract, fish meat extract, and rosemary extract Administration: Take two packs (four tablets per one pack) with water without chewing a
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Subjects aged 50 or more 4. Healthy subjects 5. Subjects who are aware of the decline in their walking ability due to discomfort in the knee joint 6. Subjects who are judged as eligible to participate in the study by the physician 7. Subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at Scr 8. Subjects whose walking time is long in the 10-meter walking test at Scr
Exclusion criteria
Exclusion criteria: Subjects who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. are undergoing or need to undergo treatment for knee disease such as knee osteoarthritis 4. have undergone or need to undergo knee or back surgery 5. may experience rheumatic pain 6. are attending an orthopedic or osteopathic clinic 7. are intensely exercising to make excessive load on the body 8. currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, bronchial asthma, coagulation disorder, prostate cancer, glaucoma, hypercholesterolemia, gastric ulcer, gout, hemophilia, hypoprothrombinemia, photosensitivity, hemorrhagic disease, convulsive disorder, aspirin sensitivity, vitamin B12 deficiency, psoriasis, hereditary eye disease such as Leber disease, red blood cell abnormality such as megaloblastic anemia or polycythemia vera, or other chronic diseases 9. have high serum calcium levels 10. plan to undergo a surgical operation between two weeks before first consumption and two weeks after last consumption 11. take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily use 12. currently taking medications (including herbal medicines) and supplements 13. are allergic to medicines and/or the test food related products 14. have allergic reactions to nonsteroidal anti-inflammatory drugs, cobalt or cobalamin 15. are pregnant, breast-feeding, and plan to become pregnant after participate in the study 16. suffer from COVID-19 17. have been enrolled in other clinical trials within the last three month before the agreement to participate in this trial or plan to participate another trial during this trial 18. are judged as ineligible to participate in the study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Walking time in 10-meter walking test at 12 weeks after consumption (12w) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The number of steps, stride length, waking rate, the number of times of standing up from the chair for 30 seconds, evaluation scores in the step test, evaluation items of Japanese knee osteoarthritis measure (JKOM) {visual analog scale (VAS) and the score of JKOM, pain and stiffness in knees, conditions in daily life, general activities, and health conditions}, evaluation items of Japan low back pain evaluation questionnaire (JLEQ) (VAS, and the score of JLEQ, low back pain related to activity of daily living, problems due to low back pain, and health and psychological condition of a month living), and high sensitivity C-reactive protein at 12w 2. Individual items of the JKOM and JLEQ questionnaire at 12w | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed