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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034771
Receipt No. R000039616
Scientific Title Verification of the efficacy and effective dose of dietary fibers on postprandial blood glucose elevation
Date of disclosure of the study information 2018/11/15
Last modified on 2019/05/09

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Basic information
Public title Verification of the efficacy and effective dose of dietary fibers on postprandial blood glucose elevation
Acronym The effect of dietary fibers on postprandial blood glucose
Scientific Title Verification of the efficacy and effective dose of dietary fibers 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 and effective dose 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, delta blood glucose levels, delta Cmax (The peak value of the 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 No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 4
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Drinking 200 mL of water with eating 150 g of cooked rice
Interventions/Control_2 Drinking 200 mL of test beverage A (low dietary fiber)with eating 150 g of cooked rice
Interventions/Control_3 Drinking 200 mL of test beverage B(high dietary fiber X) with eating 150 g of cooked rice
Interventions/Control_4 Drinking 200 mL of test beverage C(high dietary fiber Y) with eating 150 g of cooked rice
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 to alcohol
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 15

Research contact person
Name of lead principal investigator
1st name Koichi
Middle name
Last name Aizawa
Organization KAGOME CO., LTD.
Division name Innovation Division
Zip code 329-2762
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 Kazutaka
Middle name
Last name Yoshida
Organization KAGOME CO., LTD.
Division name Innovation Division
Zip code 329-2762
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 KAGOME CO., LTD.
Address 3-21-1 Nihonbashihamacho, Chuoku, Tokyo, Japan
Tel +81-3-5623-8501
Email Takuji_Hayakawa@kagome.co.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 11 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 14
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 Completed
Date of protocol fixation
2018 Year 10 Month 17 Day
Date of IRB
2018 Year 10 Month 17 Day
Anticipated trial start date
2018 Year 11 Month 15 Day
Last follow-up date
2019 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 11 Month 05 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039616

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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