UMIN-CTR Clinical Trial

Public title

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

Acronym

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

Scientific Title

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

Scientific Title:Acronym

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

Region

Japan

Condition

Healthy Japanese subjects

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To verify the effects of consumption of the test food on the discomfort of the knee joint in healthy Japanese subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

1. The measured values of the score of Japanese Knee Osteoarthritis Measure (JKOM) at 12 weeks after consumption (12w)

Key secondary outcomes

1. The measured values of the score of JKOM at four and eight weeks after consumption (4w, 8w)

2. The amounts of changes of the score of JKOM from screening (before consumption; Scr) at 4w, 8w, and 12w

3. The measured values and amount of change from Scr in each of the following items at 4w, 8w, and 12w: visual analogue scale (VAS), the scores of pain and stiffness in knees, conditions in daily life, general activities, and health conditions, individual items of the JKOM questionnaire, deoxypyridinoline (DPD), bone specific alkaline phosphatase (BAP), crosslinked N-telopeptide of type I collagen (NTx), tartrate-resistant acid phosphatase 5b (TRACP-5b), and high sensitivity C-reactive protein (CRP)

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test food: Kinkoichiro
Administration: Take seven tablets any time during the day with water

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test food: Placebo
Administration: Take seven tablets any time during the day with water

* Daily dose should be taken within the day. If you forget to take the test food, take it as soon as you remember within the day.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Male or female

3. Subjects aged 20 or more

4. Healthy subjects

5. Subjects who are aware of the discomfort of the knee joint

6. Subjects who are judged as eligible to participate in the study by the physician

7. Within the subjects who met the sixth inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at Scr

8. Within the subjects who met the seventh inclusion criteria, subjects whose JKOM score are high at Scr

Key exclusion criteria

1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction

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

3. Subjects who are undergoing or need to undergo treatment for knee disease such as knee osteoarthritis

4. Subjects who have lactose intolerance

5. Subjects who have undergone or need to undergo knee surgery

6. Subjects who may experience rheumatic pain

7. Subjects who are attending an orthopedic or osteopathic clinic

8. Subjects who are intensely exercising to make excessive load on the body

9. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, bronchial asthma, hypercalcemia, histoplasmosis, hyperparathyroidism, sarcoidosis, lymphoma, tuberculosis, or other chronic diseases

10. Subjects who use antiplatelet agent

11. Subjects who use or take "Foods for Specified Health Uses," "Foods with Functional Claims," or other functional food/beverage in daily

12. Subjects currently taking medicines (include herbal medicines) and supplements

13. Subjects who are allergic to medications and/or the test-food-related products (particularly milk, fish, egg, or chicken)

14. Subjects who are pregnant, breast-feeding, and planning to become pregnant

15. Subjects who suffer from COVID-19

16. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

17. Subjects who are judged as ineligible to participate in the study by the physician

Target sample size

60

Name of lead principal investigator

1st name	Tsuyoshi
Middle name
Last name	Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

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

TEL

03-5793-3623

Email

t-takara@takara-clinic.com

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

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

MAINICHIEGAO,INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Nerima Medical Association, Minami-machi Clinic

Name of secondary funder(s)

Organization

the ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Building, 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

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

2021

Year

10

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

66

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

Completed

Date of protocol fixation

2021

Year

10

Month

13

Day

Date of IRB

2021

Year

10

Month

13

Day

Anticipated trial start date

2021

Year

10

Month

22

Day

Last follow-up date

2022

Year

04

Month

17

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

10

Month

20

Day

Last modified on

2023

Year

03

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052291