UMIN-CTR Clinical Trial

Public title

The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink

Acronym

The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink

Scientific Title

The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink

Scientific Title:Acronym

The efficacy evaluation of the knee subjective symptoms and motor function by collagen containing drink

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of collagen containing drink on the knee subjective symptoms and motor function for 12 weeks.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

locomotive syndrome risk test, JKOM before and 6, 12 weeks after the intervention with the test drink

Key secondary outcomes

JOA, levels of change in knee joint stiffness, VAS, handgrip before and 6, 12 weeks after the intervention with the test drink

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

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Collagen containing drink are ingested for 12 consecutive weeks

Interventions/Control_2

Collagen free drink are ingested for 12 consecutive weeks

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

74

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1)Males and females at the ages of 40 to 74
(2)Subjects who are judged as stage 1 in locomotive syndrome risk test
(3)Subjects who confirmed pain of knee joint by JKOM and VAS
(4)Subjects who are classified into 0-I grade on the basis of the Kellgren-Lawrence classification. (Subjects who undiagnosed with Knee Osteoarthritis by physician)

Key exclusion criteria

(1)Subjects who exceeded the value of knee pain on JKOM, question-I : the degree of pain, more than the sum VAS value of other joint pain (e.g., ankle, elbow, finger, shoulder, back and hip)
(2)Subjects who are confirmed 30-points by JOA score, the degree of knee pain and walk ability
(3)Subjects who are suspected gouty attack with hyperuricemia
(4)Subjects who have positive rheumatoid factors on the screening test or may have rheumatic pain
(5)Subjects who have performed arthroplasty or need it
(6)Subjects who regularly take health food containing bone, joint, muscle wellness from three month before the screening test to the end of the study
(7)Subjects who regularly take medicine
(8)Subjects who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
(9)Subjects who get an intense exercise to make excessive load on the joints
(10)Subjects who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test
(11)Subjects who regularly use a stick or supporter
(12)Subjects who routinely exert an influence on the efficacy evaluation
(13)Subjects who get a diagnosis of malignancy, are under treatment for hypertension, cardiac disease, renal disease and thyroid dysfunction, and have a history of serious disorder such as hepatic disease
(14)Subjects who consume an excess amounts of alcohol
(15)Subjects who have possibility of allergy symptoms onset by the test supplement
(16)Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(17)Subjects who have participated in other clinical study within a month before the screening test or who intend to participate in study period
(18)Subjects who intend to become pregnant or lactating
(19)Subjects who are judged as unsuitable for this study by physician

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Sadao Mori

Organization

Morinaga & Co.,Ltd

Division name

Health and Wellness Headquarters

Zip code

Address

2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama

TEL

070-3864-8266

Email

s-mori-ab@morinaga.co.jp

Name of contact person

1st name
Middle name
Last name	Noriko Watanabe

Organization

TTC Co.,Ltd

Division name

Clinical Research Planning Department

Zip code

Address

Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

n.watanabe@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd

Institute

Department

Personal name

Organization

Morinaga & Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

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

Date of disclosure of the study information

2017

Year

06

Month

09

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

Completed

Date of protocol fixation

2017

Year

05

Month

25

Day

Date of IRB

Anticipated trial start date

2017

Year

06

Month

12

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

06

Month

09

Day

Last modified on

2018

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031730