UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial

Acronym

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

Scientific Title

Effects of consumption of the test food in healthy Japanese with discomfort in the knee joint: a randomized, double-blind, placebo-controlled, parallel-group trial

Scientific Title:Acronym

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

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 on discomfort in the knee joint with the test food for 12 weeks in healthy Japanese adult subjects with discomfort in the knee joint

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The total score of Japanese Knee Osteoarthritis Measure (JKOM)

* Compare the amount of change between screening (before consumption) and 12 weeks after consumption

Key secondary outcomes

1. JKOM
Assess the total score of JKOM and the scores of visual analogue scale (VAS), pain and stiffness in knees, conditions in daily life, general activities, and health conditions

2. The Japanese Orthopaedic Association score for osteoarthritic knees (JOA)
Assess JOA scores (the average in both legs, right leg, and left leg)

3. Subjective symptoms related to knee pains (VAS)

4. The 30-second chair stand test
Assess the number of times of standing up from the chair for 30 seconds

5. The 10-meter walking test
Assesse walking speed, the number of steps, stride length, and waking rate (the number of steps per time)

6. Blood test
Assess high sensitivity C-reactive protein, cleavage of type II collagen, and myoglobin

*^1-6 Assess the items at screening (before consumption) and 4, 8, and 12 weeks after consumption and calculate the amount of change or rate of change. However, the total score of JKOM assesses only the value and rate of change at 12 weeks after consumption.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 12 weeks
Test Material: Active tablets
Dosage: Take 6 tablets with water or warm water after breakfast

* If you forget to take the tablets, take tablets as soon as you remember within the day.

Interventions/Control_2

Duration: 12 weeks
Test Material: Placebo tablets
Dosage: Take 6 tablets with water or warm water after breakfast

* If you forget to take the tablets, take tablets 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. Healthy Japanese adult subjects

2. Subjects who are experiencing discomfort in the knee joint; however, subjects who are not diagnosed with any diseases by a physician

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

4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects who are judged in the Kellgren-Lawrence grade (KL grade) either 0 or 1 in X-ray at screening (before consumption)

5. Within the subjects who met the 4th inclusion criteria, subjects whose total scores of JKOM are relatively high at screening (before consumption)

Key exclusion criteria

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

2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

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

4. Subjects who are currently taking medications (including herbal medicines) and supplement
* Particularly taking anticoagulants such as warfarin

5. Subjects who experience palpitations when they walk fast

6. Subjects who are allergic to medicines and/or the test food related products

7. Subjects who are pregnant, breast-feeding, or planning to become pregnant

8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial

9. 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
Middle name
Last name	Kazuo YAMAMOTO

Organization

ORTHOMEDICO Inc.

Division name

CEO

Zip code

Address

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

TEL

03-3818-0610

Email

kazu@orthomedico.jp

Name of contact person

1st name
Middle name
Last name	Naoko SUZUKI

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

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

DHC Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

Organization

Address

Tel

Email

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)

Date of disclosure of the study information

2018

Year

07

Month

19

Day

URL releasing protocol

Unpublished

Publication of results

Published

URL related to results and publications

http://www.pieronline.jp/content/article/0386-3603/47120/2007

Number of participants that the trial has enrolled

66

Results

Kageyama M, Kobashi R, Tomobe H, Nakajima Y, Akiyoshi K, Ohmori R, Yamada A, Takahashi Y, Takara T. Effects of consumption of the test food containing glucosamine hydrochloride, methylsulfonylmethane, boswellia serrata extract, and olive extract in healthy Japanese subjects with knee joint discomfort: a randomized, double-blinded, placebo-controlled, parallel-group study. Jpn Pharmacol Ther. 2019; 47(12): 2007-2029

Results date posted

2021

Year

05

Month

27

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

01

Month

08

Day

Baseline Characteristics

Refer to the paper

Participant flow

Refer to the paper

Adverse events

Refer to the paper

Outcome measures

Refer to the paper

Plan to share IPD

Undecided

IPD sharing Plan description

To require consultation among related companies

Recruitment status

Completed

Date of protocol fixation

2018

Year

07

Month

09

Day

Date of IRB

2018

Year

07

Month

09

Day

Anticipated trial start date

2018

Year

07

Month

20

Day

Last follow-up date

2019

Year

04

Month

20

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

07

Month

19

Day

Last modified on

2021

Year

05

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038134