Healthy volunteers
Conditions
Interventions
Intake of test food 1 for 12 weeks (once a day, 3 capsules)
Intake of placebo for 12 weeks (once a day, 3 capsules)
Sponsors
Megmilk Snow Brand Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects whose age of 30 years or more and less than 65 years with knee joint pain 2) Subjects diagnosed KL grade 0 or 1 by knee X-ray 3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 1) Subjects having a medical history of rheumatism 2) Subjects having leg pain or numbness 3) Subjects having injury of semi-lunar disc or the other knee joint disease 4) Subjects having a present or past history of diseases inducing pain or arthritis, diseases related to cartilage metabolism or bone metabolism (e.g. osteoarthritis, rheumatoid arthritis, osteoporosis) 6) Subjects having a history of visiting an orthopedic surgeon frequently or having a plan to visit an orthopedic surgeon during the study 7) Subjects having a history of visiting osteopathic clinic frequently or having a plan to visit osteopathic clinic during the study 8) Subjects taking supplements or health foods labeled the function to knee joint symptoms (e.g. Foods for Specified Health Uses, Foods with Function Claims) 9) Subjects using medicines or quasi-drugs with the function to knee joint symptoms (e.g. analgesics, anti-inflammatory, vitamin B1 preparations) 10) Subjects taking foods high in lactic acid bacteria or bifidobacterium 3 days or more a week 11) Subjects taking large amounts of foods high in lactic acid bacteria or bifidobacterium 12) Subjects taking lactic acid bacteria or bifidobacterium enriched health foods 13) Subjects taking medicines containing lactic acid bacteria or bifidobacterium as active ingredients(e.g. Biofermin) 14) Subjects having the possibility of developing allergic symptoms by the test food (especially milk and dairy allergy) 15) Female subjects who are pregnant or lactating, or intending to become pregnant during the study 16) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study 17) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study 18) Subjects deemed unsuitable by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS | — |
Secondary
| Measure | Time frame |
|---|---|
| JKOM, JOA score (knee joint), knee flexion angle, Locomotive syndrome risk test, JLEQ score, Shoulder 36 (V 1.3) score, GSRS score, FSSG score | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed