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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033714
Receipt No. 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

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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
Email 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
Email ayossie10@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038205

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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