UMIN-CTR Clinical Trial

Public title

Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study

Acronym

Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function

Scientific Title

Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function: A Placebo-Controlled, Randomized, Double-Blind, Parallel-Group Study

Scientific Title:Acronym

Examination of the Effects and Safety of a Test Food Ingestion on Knee Pain and Motility Function

Region

Japan

Condition

N/A(healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine the effects and safety of a test food ingestion on knee pain and motility function with placebo-controlled, randomized, double-blind, and parallel-group method.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Japanese Knee Osteoarthritis Measure (JKOM; Screening, Week 0, Week 4, Week 12).

Key secondary outcomes

*Secondary outcomes
[1]The Japan Orthopaedic Association Score (JOA Score; Screening, Week 0, Week 4, Week 12).
[2]The 25-question geriatric locomotive function scale (Screening, Week 0, Week 4, Week 12).
[3]Stand-up test (Screening, Week 0, Week 4, Week 12).
[4]2-step test (Screening, Week 0, Week 4, Week 12).
[5]Timed up & go test (Screening, Week 12).

*Safety
[1]Blood pressure, pulsation (Screening, Week 0, Week 4, Week 12).
[2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4, Week 12).
[3]Hematologic test (Screening, Week 0, Week 12).
[4]Blood biochemical test (Screening, Week 0, Week 12).
[5]Urine analysis (Screening, Week 0, Week 12).
[6]Doctor's questions (Screening, Week 0, Week 4, Week 12).
[7]Subject's diary (From the first day of ingestion of a test material to the last day of the test).

*Other index
[1]Evaluation of knee with Kellgren-Lawrence grading system (Screening).

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

Treatment

Type of intervention

Food

Interventions/Control_1

Oral ingestion of a test food (one time in a day; 12 weeks).

Interventions/Control_2

Oral ingestion of a placebo food (one time in a day; 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

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

[1]Healthy Japanese males and females aged 40-75 years.
[2]Individuals who are healthy and have no chronic physical disease.
[3]Individuals who are aware of knee pain.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination on a designated check day.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals receiving outpatient care (except for bonesetters, chiropractors, massagers) for knee and/or low back pain.
[3]Individuals who are a patient or have a history of rheumatic disease.
[4]Individuals whose grade of Kellgren-Lawrence grading system is over Grade II.
[5]Individuals with history of palliative therapy (hyaluronic acid, steroid injection, etc.) or surgical therapy (arthroscopic osteotomy, artificial joint, bolt fixation surgery, etc.)on knees and/or waist.
[6]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders.
[7]Individuals who are a patient or have a history of receiving medical drug treatment for the past 1 month (except for temporary relief medication for headache, menstrual pain, common cold).
[8]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[9]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[11]Individuals with serious anemia.
[12]Individuals who are sensitive to test product or other foods, and medical products.
[13]Individuals having a habit to intake a food containing the component of the test food.
[14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[15]Individuals who may significantly change exercise habit or lifestyle during the study period.
[16]Individuals who are or are possibly, or are lactating.
[17]Individuals who participated in other clinical studies in the past 3 months.
[18]Individual with potential conflict of interests.
[19]Individuals judged inappropriate for the study by the principal.

Target sample size

70

Name of lead principal investigator

1st name	Yasuo
Middle name
Last name	Kobuna

Organization

Medical Cooperation Koyukai Kobuna Orthopedic Surgery

Division name

Head

Zip code

371-0813

Address

311-2 Gokanmachi Maebashi-shi Gunma 371-0813, JAPAN

TEL

+81-27-261-7600

Email

info@tes-h.co.jp

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holding Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holding Co., Ltd.

Institute

Department

Personal name

Organization

Kobayashi Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Cooperation Koyukai Kobuna Orthopedic Surgery Ethical Committee

Address

311-2 Gokanmachi Maebashi-shi Gunma 371-0813, JAPAN

Tel

+81-27-261-7600

Email

jimukyoku@tes-h.co.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

2018

Year

12

Month

14

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

2018

Year

11

Month

12

Day

Date of IRB

2018

Year

11

Month

15

Day

Anticipated trial start date

2018

Year

12

Month

14

Day

Last follow-up date

2019

Year

03

Month

16

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

12

Month

14

Day

Last modified on

2019

Year

06

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040113