N/A (healthy adults)
Conditions
Interventions
Intake the test food (capsules containing undenatured type II collagen) for 12 weeks
Intake the control food (capsules without undenatured type II collagen) for 12 weeks
Sponsors
Kyowa Trial Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Japanese male and female aged 20 to <75 years at the time of obtaining the consent for trial participation 2)Healthy participants who are not currently receiving treatment for any serious disease 3)Participants who do not have OA or RA but have discomfort in their knees 4)Participants with JKOM pain VAS 20mm or more (preferably 50mm or less) 5)Participants who can visit the designated facility on the scheduled visit date 6)Participants who provided their consent in writing after having fully understood the purpose and content of the trial
Exclusion criteria
Exclusion criteria: 1)Participants with OA (knee OA , grade II or higher according to the KL classification), RA , and gout 2)Participants with gait velocity of 1.0m/s or more at 10m walk (maximal velocity walk) during the pretest 3)Participants with body mass index 25.0 or more at the time of preliminary examination 4)Participants undergoing outpatient treatment for knee arthralgia 5)Participants who have difficulty in participating in the study due to liver, kidney, and heart diseases, respiratory disorder, endocrine disorder, metabolic disorder, neuropathy, consciousness disorder, diabetes mellitus (according to the criteria established by the Japanese Diabetes Association), and other diseases 6)Participants with a history of cardiovascular disease 7)Participants who regularly use drugs or health foods/supplements (including food for specified uses, food with function claims, and food with nutrient function claims) that may affect this study (but who can stop using them at the time informed consent was obtained is not applicable) 8)Participants with allergies related to test foods (collagen) 9)Participants who have weakness or deterioration in physical condition due to previous blood sampling 10)Participants who have donated blood (200mL or more) from the month before the start of the study to the start of the study or who are scheduled to donate blood during the study period 11)Participants participating in other clinical trials or who are within 4 weeks of completion of the study 12)Participants with alcohol polydipsia and persons who smoke excessively 13)Participants who have extremely irregular eating habits 14)Participants who do not agree with the purpose of the test, which was explained in advance 15)Participants who are determined by the principal investigator as not suitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knee joint passive range of motion | — |
Secondary
| Measure | Time frame |
|---|---|
| WOMAC, JKOM, VAS for knee discomfort (at wake up, when walking, when ascending stairs, when descending stairs, when squatting, when sitting upright, when standing up after sitting upright, when standing up from a chair, when picking up something that has fallen on the floor), JLEQ, VAS for lower back discomfort (at wake up, when walking, when ascending stairs, when descending stairs, when squatting, when sitting upright, when standing up after sitting upright, when standing up from a chair, when rolling over, when stretching the lower back, when twisting the lower back, while in crouching or forward-leaning position, when picking up something that has fallen on the floor), and the motor function (10-meter walking test (the duration and number of steps for normal and fastest walks) and stair-climbing tests) | — |
Countries
Japan
Contacts
Public ContactMegumi Takahashi
Ryusendo Co., Ltd. Development Division
Outcome results
None listed