The efficacy evaluation of test food on knee discomfort and mobility function.

Not Applicable

• Conditions: Healthy adult

• Registration Number: JPRN-UMIN000046438
• Lead Sponsor: KSO Corporation

Brief Summary

The JOA score, stair climb test, six-minute walk test, JKOM score and VAS were significantly improved by the ingestion of test supplements.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-16
• Study Start: 2023-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

1. Subjects who are under treatment, have a history, or are suspected to have rheumatoid arthritis. 2. Subjects who are under treatment or determined by the investigator to need receiving for articular diseases. 3. Subjects with history of surgical therapy (artificial joint) on knees. 4. Subjects who continuously use compress, topical cream, and/or analgesic agent etc. on knee region. 5. Subjects who have injury of semi-lunar disc or the other knee joint disease. 6. Subjects who received the surgery for chronic knee pain in the past. 7. Subjects undergoing treatment for serious chronic diseases such as hepatic disorder, renal disorder, cardiovascular disorder, cerebrovascular disorder, respiratory disorder. 8. Subjects who are unable to stop taking medications, supplements or functional foods that affect the knee joint during the study period. 9. Subjects with allergies to food ingredients contained in the test food. 10. Subjects who hope for pregnancy in the study period, pregnant women, lactating women. 11. Subjects who donated blood of over 200 mL in the past 12 weeks. 12. Subjects who had participated in a study involving the consumption of other foods or drugs or the tests to apply cosmetics and medicines within 1 month retrospectively from the time of consent. Subjects who wish to participate in other studies while participating in this study. 13. Subjects who are judged as unsuitable for the study by the investigator for other reasons.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The level of the Japan orthopaedic association Score (JOA) and mobility function tests. Amount of change in JOA and mobility function tests before and after intake.

Secondary Outcome Measures

Name	Time	Method
The level of Japanese knee osteoarthritis measure (JKOM) and visual analog scale (VAS). Amount of change in JKOM and VAS before and after intake. Safety assessment. Statistical analysis of the level and the amount of change in JOA, mobility function tests, JKOM and VAS by the Kellgren-Lawrence grading system.