UMIN-CTR Clinical Trial

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

Contact us.