UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040041 |
|---|---|
| Receipt number | R000045649 |
| Scientific Title | Function of steamed soy foods |
| Date of disclosure of the study information | 2020/04/25 |
| Last modified on | 2020/04/03 11:24:19 |
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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
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
nikawa@tokushima-u.ac.jp
Sponsor or person
Institute
FUJICCO
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045649
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
