UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030738 |
|---|---|
| Receipt number | R000034888 |
| Scientific Title | Evaluating the effect of Kori-tofu intake on Hemoglobin A1c values:randomized parallel-group comparative study |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2018/01/09 19:19:09 |
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Basic information
Public title
Evaluating the effect of Kori-tofu intake on Hemoglobin A1c values:randomized parallel-group comparative study
Acronym
Evaluating the effect of Kori-tofu intake on Hemoglobin A1c values:randomized parallel-group comparative study
Scientific Title
Evaluating the effect of Kori-tofu intake on Hemoglobin A1c values:randomized parallel-group comparative study
Scientific Title:Acronym
Evaluating the effect of Kori-tofu intake on Hemoglobin A1c values:randomized parallel-group comparative study
Region
| Japan |
Condition
Condition
Persons having HbA1c of 5.8~6.5%, except for persons receiving anti-diabetic treatment
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A pilot study revealed that Kori-tofu intake can reduce HbA1c values. This study was planned to validate the efficacy of Kori-tofu by larger-scale comparative study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c after 12-week Kori-tofu intake
Key secondary outcomes
Changes in body weight, serum levels of glucose, insulin, liver enzymes, HDL-cholesterol, LDL-cholesterol, and triglycerides after 12-week Kori-tofu intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will have powered- or cooked Kori-tofu (16.5 g/day) for 12 weeks.
Interventions/Control_2
Participants will have ordinary diet for 12 weeks.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. More than 20 years of age
2. HbA1c 5.8-6.5% without any anti-diabetic drugs
3. No serious diseases
4. No episode of abnormalities after eating kori-tofu
5. No allegy for soybeans
6. persons consented not to change daily lifestyle in the test period
7. persons consented to have kori-tofu every day in the test period
8. persons consented to particiate in this examination freely and spontaneously
Key exclusion criteria
1. HbA1c of <5.8% or >6.5% at the time of registration
2. persons under treatment of diabetes
3. patients having chronic kidney disease requiring dietary protein restriction
4. persons having a past history of abnormalities by eating kori-tofu
5. persons having soybean allergy
6. Woman during pregnancy or feeding
7. Accompanying serious diseases
8. Persons who were considered as inappropriate for the participants
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Tanaka |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Metabolic Regulation
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL
0263-37-2851
naopi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoki Tanaka |
Organization
Shinshu University Graduate School of Medicine
Division name
Department of Metabolic Regulation
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano, Japan
TEL
0263-37-2851
Homepage URL
naopi@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Asahimatsu Food Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 15 | 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
| 2017 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 09 | Day |
Last modified on
| 2018 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034888
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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