Healthy adult
Conditions
Sponsors
EP Mediate Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy males and females from 40 to 74 years of age (2)Subject who feels discomfort in their joints due to aging (3)Subject who experiences a decline in walking and muscle strength due to aging (4)Subjects who confirmed pain of knee joint by JKOM VAS and have low muscle mass (5)Subjects who can understand the purpose and content of this study and voluntarily agree to participate in this study
Exclusion criteria
Exclusion criteria: (1)Subjects who are classified into II, III or IV grade on the basis of the KL classification (2)Subjects which knee join pain is weaker than pain in other joints (3)Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability (4)Subjects who are suspected gout attack with hyperuricemia (5)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain (6)Subjects who have performed arthroplasty or need it (7)Subjects who regularly use health foods that may affect the evaluation of the study (8)Subjects who regularly use pharmaceuticals (9)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test (10)Subjects who exercise excessively (11)Subjects with a history of locomotory disease within 1 year before the screening examination (12)Subjects who use canes or supporters (13)Subjects who periodically conduct actions that may affect the evaluation of effectiveness (14)Subjects who have or have a history of severe diseases (15)Subjects who taking warfarin or those who need to take warfarin during the study period (16)Subjects who diagnosed with hypertension (17)Subjects who have unsteady lifestyle or who work manual labor (18)Subjects who drink alcohol in large quantities (19)Subjects who have at risk of developing allergies related to the test food (20)Subjects who are judged as unsuitable due to lifestyle questionnaire (21)Subjects who cannot carry out the test as instructed (22)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in the study period (23)Subjects who are in a pregnancy or lactation period in the study period (24)Subjects who are judged as unsuitable for the study by investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| JKOM | — |
Secondary
| Measure | Time frame |
|---|---|
| Locomo25, JKOOS, JOA, knee range of motion, VAS, JLEQ, 6m walk test, knee extension strength, muscle mass, bone density, P1NP, TRACP-5b, osteocalcin | — |
Countries
Japan
Contacts
Public ContactAkane Morimoto
EP Mediate Co., Ltd. Foods Department Trial Planning Section
Outcome results
None listed