UMIN-ICDS Clinical Trial

Public title

Effects of consumption of the test food on the knee joint in healthy Japanese

Acronym

Effects of consumption of the test food on the knee joint in healthy Japanese

Scientific Title

Effects of consumption of the test food on the knee joint in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on the knee joint in healthy Japanese

Region

Japan

Condition

Healthy Japanese

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To survey the effects of consumption of the test food on the knee joint in healthy Japanese.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured values of the score of Japanese Knee Osteoarthritis Measure (JKOM) {visual analog scale (VAS)} at 12 weeks after consumption (12w)

Key secondary outcomes

1. The measured values of the score of JKOM (VAS) at 6 weeks after consumption (6w)

2. The measured values of total score, "Pain and stiffness in knees" score, "Conditions in daily life" score, "General activities" score, and "Health conditions" score of the JKOM at 6w and 12w

3. Individuals whose responses to each item in the JKOM improved by one or more scales at 6w and 12w

4. The measured values of the Japanese Orthopaedic Association (JOA) score (left/right averaged, left leg, and right leg), pain on walking (left/right averaged, left leg, and right leg), pain on ascending or descending stairs (left/right averaged, left leg, and right leg), range of motion (left/right averaged, left leg, and right leg), joint swelling (left/right averaged, left leg, and right leg), high-sensitivity C-reactive protein at 12w

5. Individuals whose JOA score improved by one or more scales at 12w

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test product: Supplement containing elastin peptides derived from horse
Administration: Consume two capsules per day after lunch and before sleep

Interventions/Control_2

Duration: 12 weeks
Test product: Placebo capsule
Administration: Consume two capsules per day after lunch and before sleep

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

40

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Adults (aged >= 40 and < 75 years)

4. Healthy individuals

5. Individuals who are judged in the Kellgren-Lawrence grade (KL grade) as 0 or 1 in X-ray at screening (Scr)

6. Individuals whose score of the JKOM measured by Visual Analogue Scale: (VAS) is high at Scr

Key exclusion criteria

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product, particularly those who are allergic to horse-derived substances

7. Individuals who are pregnant, lactating, or planning to become pregnant during this study

8. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

9. Individuals who usually use "Foods for Specified Health Uses," or "Foods with Functional Claims" {e.g. N-acetylglucosamine, proteoglycan from salmon nasal cartilage (SNC), undenatured type II collagen from SNC, glucosamine hydrochloride, curcumin, elastin peptide from skipjack, or collagen peptide}

10. Individuals who engage in intense, knee joint-loading exercise (e.g., ball sports such as soccer, baseball, basketball, or jogging, running, skiing, or snowboarding)

11. Individuals who use a cane or joint support, or may use them during this study

12. Individuals who are judged as ineligible to participate in this study by the physician

Target sample size

14

Name of lead principal investigator

1st name	Takahiro
Middle name
Last name	Yamada

Organization

Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics

Division name

Director

Zip code

123-0843

Address

2F Nakazato Bldg., 2-3-13, Nishi-arai sakae-cho, Adachi-ku, Tokyo, Japan

TEL

03-5681-1133

Email

dr_yamada@orthomedico.jp

Name of contact person

1st name	Naoko
Middle name
Last name	Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

TEL

03-3818-0610

Homepage URL

Email

nao@orthomedico.jp

Institute

BIOCON (JAPAN) LTD.

Institute

Department

Personal name

Organization

BIOCON (JAPAN) LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

西新井駅前クリニック眼科整形外科 (東京都)
Nishi-Arai Ekimae Clinic Ophthalmology and Orthopedics (Tokyo, Japan)

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)

Date of disclosure of the study information

2025

Year

10

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Open public recruiting

Date of protocol fixation

2025

Year

10

Month

22

Day

Date of IRB

2025

Year

10

Month

22

Day

Anticipated trial start date

2025

Year

10

Month

27

Day

Last follow-up date

2026

Year

04

Month

09

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2025

Year

10

Month

27

Day

Last modified on

2025

Year

10

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068117