Unique ID issued by UMIN | UMIN000045592 |
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Receipt number | R000052053 |
Scientific Title | The efficacy evaluation of test food on cartilage turnover biomarkers: a randomized, double-blind, placebo-controlled trial |
Date of disclosure of the study information | 2023/04/01 |
Last modified on | 2023/10/06 09:48:18 |
The efficacy evaluation of test food on cartilage turnover biomarkers.
The efficacy evaluation of test food on cartilage turnover biomarkers.
The efficacy evaluation of test food on cartilage turnover biomarkers: a randomized, double-blind, placebo-controlled trial
The efficacy evaluation of test food on cartilage turnover biomarkers.
Japan |
Healthy adult
Not applicable | Adult |
Others
NO
To evaluate the efficacy and safety of test food on cartilage turnover biomarkers.
Safety,Efficacy
The level of cartilage turnover biomarkers.
Amount of change in cartilage turnover biomarkers before intake and after intake.
The level of visual analog scale (VAS).
Amount of change in visual analog scale (VAS) before intake and after intake.
safety assessment
Statistical analysis of the level and the amount of change in cartilage turnover biomarkers by the results of visual analog scale (VAS).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Food |
Test food
Placebo food
30 | years-old | <= |
75 | years-old | > |
Male and Female
1. Healthy males and females aged 30 to 74 years old who felt discomfort or pain of the knee.
2. Subjects who are classified into 0-I grade basis of the Kellgren-Lawrence classification.
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.
1. Subjects who are under treatment, have a history, or are suspected to have rheumatoid arthritis.
2. Subjects who have been diagnosed by the investigator as needing treatment for osteoarthritis.
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 who undergo treatment for joints other than the knee (hip, lower back, shoulder, fingers, etc.), who underwent artificial joint surgery, who received the surgery related to joints and bones within 10 years
8. Subjects undergoing treatment for serious chronic diseases such as hepatic disorder, renal disorder, cardiovascular disorder, cerebrovascular disorder, respiratory disorder.
9. Subjects who are unable to stop taking medications, supplements or functional foods that affect the knee joint during the study period.
10. Subjects with allergies to food ingredients contained in the test food.
11. Subjects who hope for pregnancy in the study period, pregnant women, lactating women.
12. Subjects who donated blood of over 200 mL in the past 12 weeks.
13. 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.
14. Subjects who are judged as unsuitable for the study by the investigator for other reasons.
90
1st name | Yasuo |
Middle name | |
Last name | Kobuna |
Kobuna Orthopedics Clinic
Director
371-0813
311-2 Gokan-machi, Maebashi-shi, Gunma
027-261-7600
info@kobunaseikei.jp
1st name | Yoshika |
Middle name | |
Last name | Komori |
KSO Corporation
Sales department
105-0023
1-9-7 Shibaura, Minato-ku, Tokyo
03-3452-7733
eigyou27@kso.co.jp
KSO Corporation
Fujifilm Corporation
Profit organization
Ethical Committee of Kobuna Orthopedics Clinic
5-656-17 Joto-machi, Maebashi-shi, Gunma
027-212-5608
sagawa@mc-connect.co.jp
NO
2023 | Year | 04 | Month | 01 | Day |
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000052053
Published
https://www.pieronline.jp/content/article/0386-3603/51050/675
90
CPII and VAS were significantly improved by the ingestion of test supplements.
2023 | Year | 10 | Month | 06 | Day |
Healthy males and females aged 30 to 74 years old who felt discomfort or pain of the knee.
Enrolled (n=90)
Completed (n=89)
Analysed (n=81)
No adverse effects were observed in the test supplements.
cartilage turnover biomarkers, VAS
Main results already published
2021 | Year | 08 | Month | 26 | Day |
2021 | Year | 08 | Month | 26 | Day |
2021 | Year | 11 | Month | 22 | Day |
2022 | Year | 05 | Month | 14 | Day |
2021 | Year | 09 | Month | 28 | Day |
2023 | Year | 10 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052053
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