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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036443
Receipt No. R000041378
Scientific Title Effects of fermented okara consumption at breakfast on diurnal blood glucose responses
Date of disclosure of the study information 2019/04/15
Last modified on 2019/04/08

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Basic information
Public title Effects of fermented okara consumption at breakfast on diurnal blood glucose responses
Acronym Effects of fermented okara consumption at breakfast on diurnal blood glucose responses
Scientific Title Effects of fermented okara consumption at breakfast on diurnal blood glucose responses
Scientific Title:Acronym Effects of fermented okara consumption at breakfast on diurnal blood glucose responses
Region
Japan Asia(except Japan)

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the present study is to examine the effects of fermented okara consumption at breakfast on diurnal blood glucose responses.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose concentration
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
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Acute ingestion of placebo
Interventions/Control_2 Acute ingestion of unfermented okara
Interventions/Control_3 Acute ingestion of fermented okara
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
21 years-old <=
Age-upper limit
79 years-old >=
Gender Male
Key inclusion criteria 21 years-old <=, 80 years-old >
Obtained written informed consent from the participant before participation
Key exclusion criteria 1) Diagnosed with diabetes and dyslipidemia by a doctor and on medication or supplementation that influence metabolism
2) Those who are an anti-depressant, insomnia medication and steroid are excluded. Those suffering from sleep apnea syndrome and obese (BMI>35kg/m2) are also excluded
3) Smoker
4) Those who have pacemaker or any other metal implant internally / externally (except silver teeth implant)
5) Those who perform shift work/ travel 2 weeks before intervention
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Shigenobu
Middle name
Last name Shibata
Organization Waseda University
Division name Faculty of Science and Engineering
Zip code 162-8480
Address 2-2 Wakamatsu-cho, Shinjuku
TEL 03-5369-7318
Email shibatas@waseda.jp

Public contact
Name of contact person
1st name Masaki
Middle name
Last name Takahashi
Organization Waseda University
Division name Organization for University Research Initiatives
Zip code 139651
Address 500 Dover Road, Block T11A Level 4, Singapore
TEL +6564789721
Homepage URL
Email m-takahashi@aoni.waseda.jp

Sponsor
Institute Waseda University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Review Procedures concerning Research with Human Subjects, Waseda University
Address 1-104, Totsukamachi, Shinjuku-ku, Tokyo, 169-8050, JAPAN
Tel 03-5272-1639
Email rinri@list.waseda.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
2019 Year 04 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
2019 Year 03 Month 27 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 15 Day
Last follow-up date
2022 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
2019 Year 04 Month 08 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041378

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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