UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045592
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

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Basic information

Public title

The efficacy evaluation of test food on cartilage turnover biomarkers.

Acronym

The efficacy evaluation of test food on cartilage turnover biomarkers.

Scientific Title

The efficacy evaluation of test food on cartilage turnover biomarkers: a randomized, double-blind, placebo-controlled trial

Scientific Title:Acronym

The efficacy evaluation of test food on cartilage turnover biomarkers.

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy and safety of test food on cartilage turnover biomarkers.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The level of cartilage turnover biomarkers.
Amount of change in cartilage turnover biomarkers before intake and after intake.

Key secondary outcomes

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).


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Test food

Interventions/Control_2

Placebo food

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key 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 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.

Key exclusion criteria

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.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Yasuo
Middle name
Last name Kobuna

Organization

Kobuna Orthopedics Clinic

Division name

Director

Zip code

371-0813

Address

311-2 Gokan-machi, Maebashi-shi, Gunma

TEL

027-261-7600

Email

info@kobunaseikei.jp


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

eigyou27@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Fujifilm Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethical Committee of Kobuna Orthopedics Clinic

Address

5-656-17 Joto-machi, Maebashi-shi, Gunma

Tel

027-212-5608

Email

sagawa@mc-connect.co.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 04 Month 01 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000052053

Publication of results

Published


Result

URL related to results and publications

https://www.pieronline.jp/content/article/0386-3603/51050/675

Number of participants that the trial has enrolled

90

Results

CPII and VAS were significantly improved by the ingestion of test supplements.

Results date posted

2023 Year 10 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy males and females aged 30 to 74 years old who felt discomfort or pain of the knee.

Participant flow

Enrolled (n=90)
Completed (n=89)
Analysed (n=81)

Adverse events

No adverse effects were observed in the test supplements.

Outcome measures

cartilage turnover biomarkers, VAS

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2021 Year 08 Month 26 Day

Date of IRB

2021 Year 08 Month 26 Day

Anticipated trial start date

2021 Year 11 Month 22 Day

Last follow-up date

2022 Year 05 Month 14 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 09 Month 28 Day

Last modified on

2023 Year 10 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052053


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name