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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036045
Receipt No. R000041048
Scientific Title Verification of the dietary fibers' efficacy on postprandial blood glucose elevation
Date of disclosure of the study information 2019/03/15
Last modified on 2019/02/28

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Basic information
Public title Verification of the dietary fibers' efficacy on postprandial blood glucose elevation
Acronym The effect of dietary fibers on postprandial blood glucose
Scientific Title Verification of the dietary fibers' efficacy on postprandial blood glucose elevation
Scientific Title:Acronym The effect of dietary fibers on postprandial blood glucose
Region
Japan

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

Objectives
Narrative objectives1 To verify the efficacy of dietary fibers on postprandial blood glucose elevation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood glucose levels, the peak value of blood glucose levels, delta blood glucose levels, delta Cmax (the peak value of delta blood glucose levels), IAUC (areas calculated based on the change of delta blood glucose levels)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is 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 Drinking placebo beverage with eating 150 g of cooked rice
Interventions/Control_2 Drinking test beverage A (containing dietary fiber X) with eating 150 g of cooked rice
Interventions/Control_3 Drinking test beverage B (containing dietary fiber Y) with eating 150 g of cooked rice
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 Subjects who satisfy the following conditions
1) Who do not fit key exclusion criteria
2) Who provide written informed consents
Key exclusion criteria 1)Who has abnormal glucose tolerance in medical check-ups for the prior year
2)Who has food allergy to the test meals
3)Who has remarkable hypersensitivity
4)Who will get pregnant or breast-feed during the study period
5)Who join other human studies
6)Who are judged unsuitable for this study by principal investigator
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Aizawa
Organization KAGOME CO., LTD.
Division name Innovation Division
Zip code
Address 17 Nishitomiyama, Nasushiobara. Tochigi, Japan
TEL +81-287-36-2935
Email Koichi_Aizawa@kagome.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazutaka Yoshida
Organization KAGOME CO., LTD.
Division name Innovation Division
Zip code
Address 17 Nishitomiyama, Nasushiobara. Tochigi, Japan
TEL +81-287-36-2935
Homepage URL
Email Kazutaka_Yoshida@kagome.co.jp

Sponsor
Institute KAGOME CO., LTD
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 03 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 02 Month 26 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 11 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
2019 Year 02 Month 28 Day
Last modified on
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041048

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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