UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on maintaining muscular strength in healthy subjects

Acronym

Effects of consumption of the test food on maintaining muscular strength in healthy subjects

Scientific Title

Effects of consumption of the test food on maintaining muscular strength in healthy subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on maintaining muscular strength in healthy 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 muscular strength in healthy subjects

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

The measured value of the muscle mass at 24 weeks after consumption (24w)

Key secondary outcomes

1. The measured value of the muscle mass at 12 weeks after consumption (12w)

1-2. The change of the muscle mass from screening (before consumption; Scr) to 12w and 24w.

2. The measured values and amounts of changes from Scr of the following items at 12w and 24w: grip strength, walking time, number of steps, stride length, walking rate (the number of steps per time), normal walking speed, maximum walking speed, Locomo 25 total score, visual analog scale (VAS) of Japan Low Back Pain Evaluation Questionnaire (JLEQ), JLEQ total score, body fat percentage, body fat mass, lean body mass, high sensitivity C-reactive protein (CRP), total procollagen type I N-terminal propeptide (P1NP), bone-specific alkaline phosphatase (BAP), the Japanese Orthopaedic Association (JOA) hip score (pain, range of motion, walking ability, and activities of daily living), JOA shoulder score (pain, function, range of motion, X-ray score, and joint stability score), JOA lumbar spine score (subjective symptoms score, objective symptoms score ,activities of daily living, and urinary bladder function)

3. The measured values of the scores of the questionnaire (each item of Locomo 25, JLEQ, JOA hip score, JOA shoulder score, and JOA lumbar spine score) at 12w and 24w

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

Treatment

Type of intervention

Food

Interventions/Control_1

Duration: 24 weeks
Test food: Tablet containing salmon nasal cartilage-derived proteoglycan
Administration: Take one tablet after dinner with water

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

Interventions/Control_2

Duration: 24 weeks
Test food: Placebo
Administration: Take one tablet after dinner with water

* Daily dose should be taken within the day. If you forget to take the capsule, 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 aged 20 or more

3. Healthy subjects

4. Subjects who feel declining in their muscular strength

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

6. Subjects who satisfy more than two conditions out of the following conditions will be excluded from this study
a. grip strength is less than 28 kg (males), or less than 18 kg (females)
b. normal walking speed is less than 1 m/s
c. skeletal muscle mass is less than 7.0 kg/m² (males), or less than 5.7 kg/m² (females)

7. Subjects who have relatively low values of the muscle mass

Key exclusion criteria

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

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

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

4. Subjects who are diagnosed with sarcopenia

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

6. Subjects who currently taking medications (including herbal medicines) and supplements

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

8. Subjects who are pregnant, lactation, or planning to become pregnant

9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial

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

Target sample size

52

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

NIHON PHARMACEUTICAL CO., LTD.

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

2020

Year

12

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

56

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

11

Month

25

Day

Date of IRB

2020

Year

11

Month

25

Day

Anticipated trial start date

2020

Year

12

Month

11

Day

Last follow-up date

2021

Year

09

Month

10

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

12

Month

10

Day

Last modified on

2023

Year

03

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048752