UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033714 |
|---|---|
| Receipt number | R000038205 |
| Scientific Title | A study of the suppressive effect of noodle containing soy bean on elevation of plasma glucose level in healthy adults. |
| Date of disclosure of the study information | 2018/08/13 |
| Last modified on | 2020/08/11 19:24:55 |
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Basic information
Public title
A study of the suppressive effect of noodle containing soy bean on elevation of plasma glucose level in healthy adults.
Acronym
A study of the suppressive effect of noodle containing soy bean on elevation of plasma glucose level in healthy adults.
Scientific Title
A study of the suppressive effect of noodle containing soy bean on elevation of plasma glucose level in healthy adults.
Scientific Title:Acronym
A study of the suppressive effect of noodle containing soy bean on elevation of plasma glucose level in healthy adults.
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyse the suppression effect of noodle containing soy bean on plasma glucose.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
plasma glucose elevation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
normal noodle, once 300kcal
Interventions/Control_2
noodle containing 10% soy bean, 300kcal
Interventions/Control_3
noodle containing 33% soy bean, 300kcal
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
subjects with HbA1c 5.5 to 6.4 % or fasting plasma glucose 100 to 125 mg/dL in the last 1 year check-up
Key exclusion criteria
subjects with HbA1c >=6.5 or fasting plasma glucose >=126mg/dL
diabetes patients under treatment
patients with severe constipation
subjects have allergy allergy for wheat or soy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Gunma University Hospital
Division name
Department of Clinical Laboratory Medicine
Zip code
371-8511
Address
3-39-22, Showamachi, Maebashi-shi, Gunma, 371-8511, Japan
TEL
027-220-8576
ayossie10@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Yoshida |
Organization
Gunma University Hospital
Division name
Department of Clinical Laboratory Medicine
Zip code
371-8511
Address
3-39-22, Showamachi, Maebashi-shi, Gunma, 371-8511, Japan
TEL
027-220-8576
Homepage URL
ayossie10@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
De JAPAN
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
the Gunma University Ethical Review Board for Medical Research Involving Human Subjects
Address
3-39-22, Showamachi, Maebashi-shi, Gunma, 371-8511, Japan
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
None
Publication of results
Unpublished
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
20
Results
LGI powder did not suppress the elevation of postload glucose.
Results date posted
| 2020 | Year | 08 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
20 men without diagnosis of diabetes
Participant flow
After 75gOGTT, participants ate noodles with or without containing LGI power and took blood sampling over time
Adverse events
None
Outcome measures
postload glucose and insulin
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 10 | Day |
Last modified on
| 2020 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038205
