UMIN-ICDS Clinical Trial

Public title

A study of the effects of eating steamed Miyadaizu soybeans for 4 weeks on muscle strength and muscle mass in adults without regular exercise habits

Acronym

Effects of Steamed Miyadaizu Soybean Consumption on Muscle Strength

Scientific Title

Effects of Daily Consumption of Steamed Miyadaizu Soybeans on Muscle Strength in Adults with Low Levels of Habitual Physical Activity: A Randomized, Open-Label, Parallel-Group Trial

Scientific Title:Acronym

Effects of Steamed Miyadaizu Soybean Consumption on Muscle Strength

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To explore the effects of continuous consumption of steamed Miyadaizu soybeans on muscle strength and muscle mass in healthy adults aged 40-69 years with low levels of habitual physical activity and no regular exercise habits.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in handgrip strength from baseline to Week 4.

Key secondary outcomes

1. Handgrip strength (measured values).
2. Anthropometric measurements: body weight and body mass index (BMI) (measured values and changes from baseline to Week 4).
3. Body composition measurements: muscle mass, appendicular skeletal muscle mass, skeletal muscle mass index (SMI), fat-free mass, fat-free mass index (FFMI), fat mass, and body fat percentage (measured values and changes from baseline to Week 4).
4. Physical function measurements: muscle strength, quickness, stabilization time, and lateral sway (measured values and changes from baseline to Week 4).
5. Urinary equol levels corrected for urinary creatinine (measured values and changes from baseline to Week 4).
6. Urinary indoxyl sulfate levels (measured values and changes from baseline to Week 4).
7. Adverse events.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

50 g/day of steamed Miyadaizu soybeans for 4 weeks

Interventions/Control_2

No consumption of steamed Miyadaizu soybeans for 4 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

20

years-old

<=

Age-upper limit

69

years-old

>=

Gender

Male and Female

Key inclusion criteria

1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Japanese men and women aged 40-69 years at the time of informed consent.
3. Subjects classified as having low physical activity according to the international physical activity questionnaire-short form (IPAQ-SF)
4. Subjects who do not meet the definition of a regular exercise habit in the National Health and Nutrition Survey of Japan: exercise causing light sweating for at least 30 minutes per session, at least 2 days per week, for at least 1 year.
5. Subjects who have no clinical abnormality by screening tests.
6. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.

Key exclusion criteria

1. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular, dermatological, and/or mental disease, or who have history of those disease.
2. Subjects who have a serious injury or surgical history within 12weeks prior to this study.
3. Pre-or post-menopausal women having obvious changes in physical condition.
4. Subjects unable to safely undergo handgrip strength measurement, the sit-to-stand test, or body composition measurement.
5. Subjects using an implantable medical device such as a cardiac pacemaker.
6. Subjects with an allergy to soybeans or any test-food ingredient, or who cannot consume 50 g of soybeans per day.
7. Subjects who habitually used soy-derived health foods or supplements (e.g., isoflavones or equol) within the past 3 months.
8. Subjects who used drugs with anabolic effects (e.g., steroids) or protein-based health foods/supplements within the past 3 months.
9. Subjects who have continuously used antibiotics for more than 1 week within the past 3 months.
10. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 60g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence.
11. Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study or subjects who plan to donate blood during this study.
12. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study.
13. Subjects who have cognitive disorder or who have possibility of the disorder.
14. Subjects who participate and take the study drug in other clinical trials within four weeks prior to this study.
15. Subjects who are judged as unsuitable for this study by the principal investigator or sub investigators.

Target sample size

30

Name of lead principal investigator

1st name	Yasuji
Middle name
Last name	Arimura

Organization

University of Miyazaki

Division name

Department of Health Care Research, Organization for Promotion of Research and Industry-Academic Regional Collaboration, University of Miyazaki (Kiyotake Branch)

Zip code

889-1692

Address

Kihara5200, Kiyotake, Miyazaki889-1692, Japan

TEL

+81985-85-9577

Email

yasuji_arimura@med.miyazaki-u.ac.jp

Name of contact person

1st name	Yasuji
Middle name
Last name	Arimura

Organization

University of Miyazaki

Division name

Department of Health Care Research, University of Miyazaki (Kiyotake Branch)

Zip code

889-1692

Address

Kihara5200, Kiyotake, Miyazaki889-1692, Japan

TEL

+81985-85-9577

Homepage URL

Email

yasuji_arimura@med.miyazaki-u.ac.jp

Institute

University of Miyazaki

Institute

Department

Personal name

Organization

University of Miyazaki

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Kenko Shokuhin Kogyo Co., Ltd.

Organization

Research Ethics Committee of University of Miyazaki

Address

Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan

Tel

+81985-85-9010

Email

igakubu_kenkyu@med.miyazaki-u.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

2026

Year

09

Month

20

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

Preinitiation

Date of protocol fixation

2026

Year

08

Month

13

Day

Date of IRB

Anticipated trial start date

2026

Year

10

Month

01

Day

Last follow-up date

2027

Year

03

Month

26

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

09

Month

12

Day

Last modified on

2026

Year

09

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071956