Effects of test food intake on knee joints, muscle strength, and bones in healthy adults
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000052712
- Lead Sponsor
- EP Mediate Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 58
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method JKOM
- Secondary Outcome Measures
Name Time Method ocomo25, JKOOS, JOA, knee range of motion, VAS, JLEQ, 6m walk test, knee extension strength, muscle mass, bone density, P1NP, TRACP-5b, osteocalcin