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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | Healthy people with insufficient exercise | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tokushima University Graduate School
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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 |
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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 | |
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 |
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 |
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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 |
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Anticipated trial start date |
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Date analysis concluded |
Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |