UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051682 |
|---|---|
| Receipt number | R000058976 |
| Scientific Title | Effect of continuous intake of low sodium Kori-Tofu on blood pressure in Japanese |
| Date of disclosure of the study information | 2023/07/22 |
| Last modified on | 2023/07/21 17:29:42 |
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Basic information
Public title
A study on weight loss effect of Kori-Tofu
Acronym
A weight loss effect of Kori-Tofu
Scientific Title
Effect of continuous intake of low sodium Kori-Tofu on blood pressure in Japanese
Scientific Title:Acronym
Effect of intake of Kori-Tofu on blood pressure
Region
| Japan |
Condition
Condition
obesity, hypertension
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of kori-dofu intake on body weight, waist circumference, and blood pressure.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
body weight, height, body fat percentage, waist circumference, and blood pressure
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of Kori-tofu for 8 weeks
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
general adult
Key exclusion criteria
soy allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tomotake |
Organization
Iida Junior College
Division name
Department of Life Science
Zip code
3958567
Address
610 Matsuo, Iida, Nagano, Japan
TEL
0265224460
tomotake@iidawjc.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Tomotake |
Organization
Iida Junior College
Division name
Department of Life Science
Zip code
3958567
Address
610 Matsuo, Iida, Nagano, Japan
TEL
0265224460
Homepage URL
tomotake@iidawjc.ac.jp
Sponsor or person
Institute
Iida Junior College
Institute
Department
Personal name
Funding Source
Organization
Iida Junior College
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iida Junior College Research Ethics Committee
Address
610 Matsuo, Iida, Nagano, Japan
Tel
0265224460
tomotake@iida.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 22 | 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
58
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
Completed
Date of protocol fixation
| 2020 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058976
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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