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

The efficacy evaluation of test food on knee discomfort and mobility function: a randomized, double-blind, placebo-controlled trial - The efficacy evaluation of test food on knee discomfort and mobility function.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000046438
Enrollment
160
Registered
2023-04-01
Start date
2022-02-14
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult

Interventions

Sponsors

KSO Corporation
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy males and females aged 30 to 74 years old who felt discomfort or pain of the knee. 2. Subjects who are determined by the investigator to be unnecessary to receive outpatient care for knee. 3. Subjects who got adequate explanation about the purpose and details of the examination, have the capacity to consent, voluntarily participate in understanding, and agree to participate in the examination in writing.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactYoshika Komori

KSO Corporation Sales department

eigyou27@kso.co.jp03-3452-7733

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026