UMIN-CTR Clinical Trial

Public title

Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects

Acronym

Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects

Scientific Title

Effects of consumption of the test food on skeletal muscle in healthy Japanese subjects: a randomized, placebo-controlled, double-blind, parallel-group comparison study

Scientific Title:Acronym

Effects of consumption of the test food on skeletal muscle in healthy Japanese 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 skeletal muscle in healthy Japanese subjects

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Lean mass at 12 weeks after consumption (12w)

Key secondary outcomes

Cross-sectional area of rectus abdominis muscle, cross-sectional area of abdominal oblique muscle, total cross-sectional area of rectus abdominis muscle and abdominal oblique muscle, grip strength (right hand, left hand, and both hands average), the number of times of standing up from the chair for 30 seconds, the number of times of raising upper body for 30 seconds, waist circumference, hip circumference, body weight, body mass index, body fat percentage, fat mass (right arm, left arm, right leg, left leg, and trunk (torso)), and muscle mass {right arm, left arm, right leg, left leg, and trunk (torso)} at 12w

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

Institution is not considered as adjustment factor.

Blocking

Concealment

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Food	Behavior,custom

Interventions/Control_1

Duration: 12 weeks
Test food: Food containing yeast extract
Administration: Dissolve one packet with water and drink it right after waking up

*If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day.
*Perform training at your home with the following content three times a week (at least one day between training days) during the test period:
(1) Squats 15 times x three sets
(2) Upper body raises 15 times x three sets

Interventions/Control_2

Duration: 12 weeks
Test food: Food containing whey extract
Administration: Dissolve one packet with water and drink it right after waking up

*If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day.
*Perform training at your home with the following content three times a week (at least one day between training days) during the test period:
(1) Squats 15 times x three sets
(2) Upper body raises 15 times x three sets

Interventions/Control_3

Duration: 12 weeks
Test food: Placebo food
Administration: Dissolve one packet with water and drink it right after waking up

*If you forget to take the test food, take it as soon as you remember within the day. Daily dose should be taken within the day and not carried over to the next day.
*Perform training at your home with the following content three times a week (at least one day between training days) during the test period:
(1) Squats 15 times x three sets
(2) Upper body raises 15 times x three sets

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male

Key inclusion criteria

1. Japanese

2. Men

3. Adults

4. Subjects aged less than 75

5. Healthy subjects

6. Subjects whose BMI are 23 kg/m² or more and less than 30 kg/m²

7. Subjects whose lean mass are low

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 have lactose intolerance

5. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily

6. Subjects currently taking medicines (include herbal medicines) and supplements

7. Subjects who are allergic to medications and/or the test-food-related products (particularly milk)

8. Subjects who are pregnant, breast-feeding, and planning to become pregnant

9. Subjects who suffer from COVID-19

10. Subjects who cannot perform the specified training

11. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial

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

Target sample size

57

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

Nakahara 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

2022

Year

06

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

63

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

2022

Year

06

Month

15

Day

Date of IRB

2022

Year

06

Month

15

Day

Anticipated trial start date

2022

Year

06

Month

23

Day

Last follow-up date

2022

Year

12

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

06

Month

21

Day

Last modified on

2024

Year

04

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054838