UMIN-CTR Clinical Trial

Public title

The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function

Acronym

The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function

Scientific Title

The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function

Scientific Title:Acronym

The efficacy evaluation of the dietary supplement on movement of the knee joint and walking function

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the efficacy of ingestion of the dietary supplement containing proteoglycan for 12 weeks on movement of the knee joint and walking function

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Timed Up & Go Test
6-minute walking

Key secondary outcomes

JKOM
Tinetti falls efficacy scale
Two-step test
Knee Extension Force
30-s chair-stand test

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

Ingestion of test food containing proteoglycan for 12 weeks

Interventions/Control_2

Ingestion of placebo for 12 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

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Males and females aged 40 and over
(2) Subjects who are judged not to need to be treated for their knees by orthopedist
(3) Subjects who have fear of falling
(4) Subjects with long seconds on Timed Up & Go Test

Key exclusion criteria

Subjects
(1) who are suspected gouty attack with hyperuricemia
(2) who have positive rheumatoid factors on the screening test or may have rheumatic pain
(3) who have performed arthroplasty on the joints or need it
(4) who regularly take health food which may affect joints or muscles
(5) who take medicine regularly
(6) who have been performed intra-articular hyaluronic acid or steroid drug injection within a year before the screening test
(7) who get an intense exercise to make excessive load on the joints
(8) who have a history of the disorder related to bone and joint such as fracture and sprain within a year before the screening test
(9) who regularly use a stick or supporter
(10) who periodically conduct actions that may affect the evaluation of effectiveness
(11) who are under treatment of diseases on the joints
(12) who have severe diseases or have a history of such serious disorders
(13) who are under treatment or have a history of mental diseases
(14) who have unsteady lifestyle or who work manual labor
(15) who drink a lot
(16) who have possibilities for emerging allergy onset related to the study
(17) who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(18) who have participated in other clinical study within a month before the screening test or who intend to participate in the study period
(19) who are in a pregnancy or lactation period in the study period
(20) who are judged as unsuitable due to lifestyle questionnaire
(21) who regularly smoke
(22) who cannot carry out the test as instructed
(23) who are judged as unsuitable for the study by investigator for other reasons

Target sample size

54

Name of lead principal investigator

1st name	Yukihiro
Middle name
Last name	Takase

Organization

DyDo DRINCO, INC.

Division name

Healthcare Business Department

Zip code

530-0005

Address

2-7, Nakanoshima 2-chome, Kita-ku, Osaka, Japan

TEL

06-6222-2600

Email

takase@dydo.co.jp

Name of contact person

1st name	Mariko
Middle name
Last name	Kondo

Organization

EP Mediate Co., Ltd.

Division name

TTC center Clinical Research Planning Department

Zip code

162-0822

Address

Tsuruya Bldg., 2-23, Shimomiyabi-cho, Shinjuku-ku, Tokyo

TEL

03-5657-4983

Homepage URL

Email

kondo793@eps.co.jp

Institute

EP Mediate Co., Ltd.

Institute

Department

Personal name

Organization

DyDo DRINCO, INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguroku, Tokyo

Tel

03-6452-2712

Email

t.saito@ttc-smo.jp

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

2021

Year

01

Month

20

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

54

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

2020

Year

12

Month

24

Day

Date of IRB

2020

Year

12

Month

24

Day

Anticipated trial start date

2021

Year

01

Month

21

Day

Last follow-up date

2021

Year

06

Month

05

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

01

Month

19

Day

Last modified on

2022

Year

01

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049151