Healthy adult
Conditions
Interventions
Collagen containing drink are ingested for 12 consecutive weeks
Collagen free drink are ingested for 12 consecutive weeks
Sponsors
TTC Co.,Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Males and females at the ages of 40 to 74 (2)Subjects who are judged as stage 1 in locomotive syndrome risk test (3)Subjects who confirmed pain of knee joint by JKOM and VAS (4)Subjects who are classified into 0-I grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)
Exclusion criteria
Exclusion criteria: (1)Subjects who exceeded the value of knee pain on JKOM, question-I : the degree of pain, more than the sum VAS value of other joint pain (e.g., ankle, elbow, finger, shoulder, back and hip) (2)Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability (3)Subjects who are suspected gouty attack with hyperuricemia (4)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain (5)Subjects who have performed arthroplasty or need it (6)Subjects who regularly take health food containing bone, joint, muscle wellness from three month before the screening test to the end of the study (7)Subjects who regularly take medicine (8)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test (9)Subjects who get an intense exercise to make excessive load on the joints (10)Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test (11)Subjects who regularly use a stick or supporter (12)Subjects who routinely exert an influence on the efficacy evaluation (13)Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease (14)Subjects who consume an excess amounts of alcohol (15)Subjects who have possibility of allergy symptoms onset by the test supplement (16)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (17)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period (18)Subjects who intend to become pregnant or lactating (19)Subjects who are judged as unsuitable for this study by physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| locomotive syndrome risk test, JKOM before and 6, 12 weeks after the intervention with the test drink | — |
Secondary
| Measure | Time frame |
|---|---|
| JOA, levels of change in knee joint stiffness, VAS, handgrip before and 6, 12 weeks after the intervention with the test drink | — |
Countries
Japan
Contacts
Public ContactNoriko Watanabe
TTC Co.,Ltd Clinical Research Planning Department
Outcome results
None listed