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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040041
Receipt No. R000045649
Scientific Title Function of steamed soy foods
Date of disclosure of the study information 2020/04/25
Last modified on 2020/04/03

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Basic information
Public title Effects of continuous intake of steamed soy foods on muscle mass and strength of healthy people with insufficient exercise
Acronym Soy foods
Scientific Title Function of steamed soy foods
Scientific Title:Acronym Soy
Region
Japan

Condition
Condition Healthy people with insufficient exercise
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although soy protein has been shown to exhibit anti-muscle atrophy, the utility of whole soybeans is not yet well understood. Tofu and soy milk rich in soy protein, but other active ingredients may have escaped. Therefore, the anti-muscular atrophy effect of steamed soybeans as whole soybeans that are easy to eat and easy to digest and absorb is examined in humans with insufficient exercise.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Measurement of muscle mass and intramuscular fat mass by MRI examination,
Grip strength, walking speed measurement, vertical jump measurement
Key secondary outcomes Body weight

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Eating steamed soy food for 30 days
Interventions/Control_2 Non-eating steamed soy food
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria healthy humans with insufficient exercise
Key exclusion criteria 1) Patients who are currently in treatment or have a disease.
2) People who are currently treating with diet or exercise therapy under the supervision of a doctor
3) People who have a pacemaker or metal inside
4) People who are pregnant, may become pregnant, or are breastfeeding
5) People who have soy food allergy
6) Patients with a history of severe liver, kidney, or heart disease
7) People who have arrhythmia and severe anemia
8) People who take medicines, health foods, or supplements that may affect the test results
9) Others who are not qualified by the Principal Investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Nikawa
Organization Tokushima University Graduate School
Division name Institute of Medical Biosciences
Zip code 770-8503
Address 3-18-15 Kuramoto-cho, Tokushima 770-8503
TEL 088-633-9248
Email nikawa@tokushima-u.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Nikawa
Organization Tokushima University Graduate School
Division name Institute of Medical Biosciences
Zip code 770-8503
Address 3-18-15 Kuramoto-cho, Tokushima 770-8503
TEL 088-633-9248
Homepage URL
Email nikawa@tokushima-u.ac.jp

Sponsor
Institute FUJICCO
Institute
Department

Funding Source
Organization FUJICCO
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Integrate, Co., LTD.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Board, Tokushima University Hospital
Address 2-50-1 Kuramoto-cho, Tokushima 770-8503
Tel 0886-15-8512
Email awachiken@tokushima-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 徳島大学病院

Other administrative information
Date of disclosure of the study information
2020 Year 04 Month 25 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2020 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2020 Year 04 Month 25 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 04 Month 03 Day
Last modified on
2020 Year 04 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045649

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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