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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021766
Receipt No. R000024060
Scientific Title Glycemic response study of beverages containing barley syrup with beta-glucan-randomaised, placebo-controled double blind design
Date of disclosure of the study information 2016/04/04
Last modified on 2016/09/13

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Basic information
Public title Glycemic response study of beverages containing barley syrup with beta-glucan-randomaised, placebo-controled double blind design
Acronym Glycemic response study of beverages containing barley syrup with beta-glucan
Scientific Title Glycemic response study of beverages containing barley syrup with beta-glucan-randomaised, placebo-controled double blind design
Scientific Title:Acronym Glycemic response study of beverages containing barley syrup with beta-glucan
Region
Japan

Condition
Condition Healthy subjects
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Measurement of glycemic response of beverages containing barley syrup with beta-glucan.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postprandial blood glucose level
Measurement of blood glucose level on a day when test foods were eaten.
Incremental blood glucose area under the curve
Postprandial blood glucose level after boiled rice were eaten
Incremental blood glucose area under the curve after boiled rice were eaten
Key secondary outcomes Postprandial blood glucose level,
Postprandial maximum blood glucose level, and Insulin level
Postprandial 120 minutes blood glucose level, and Insulin level
Hemoglobin A1c

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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Glucose solution as reference (75g/225ml) - wash out period (at least 1 week) - beverages containing barley syrup with beta glucan- wash out period (at least 1 week) - beverages containing barley syrup
Interventions/Control_2 Glucose solution as reference (75g/225ml) - wash out period (at least 1 week) - beverages containing barley syrup - wash out period (at least 1 week) - beverages containing barley syrup with beta glucan
Interventions/Control_3
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
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1) Subjects who don't has abnormal glucose tolerance and don't take diabetes drug.
2) Subjects who is between 18 and 65 years old.
3) Subjects who wrote informed consent.
4) Subjects who don't join other human studies within one month.
5) Subjects who are judged as suitable for the study by the invesigator.
6) Subjects whose plasma glucose blood level or OGTT glucose blood level is wihtin 2SD by a statistical analysis.
Key exclusion criteria 1) Subjects who has abnormal glucose tolerance or take diabetes drug.
2) Subjects who is under 18 or over 65 years old.
3) Subjects who don't write informed consent.
4) Subjects who join other human studies within one month.
5) Subjects who are judged as unsuitable for the study by the invesigator.
6) Subjects whose plasma glucose blood level or OGTT glucose blood level is beyond 2SD by a statistical analysis.
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Seiichiro Aoe
Organization Otsuma Women&#39;s University
Division name Faculty of Home Economics
Zip code
Address 12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL 03-5275-6048
Email s-aoe@otsuma.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naoshi Kamata
Organization GUN EI Chemical Industry CO., LTD.
Division name Foodstuffs Group
Zip code
Address 700 Shukuorui-machi, Takasaki-shi, Gunma 370-0032, Japan
TEL 027-353-1847
Homepage URL
Email n-kamata@gunei-chemical.co.jp

Sponsor
Institute GUN EI Chemical Industry CO., LTD.
Institute
Department

Funding Source
Organization GUN EI Chemical Industry CO., LTD.
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
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 医療法人樹心会 角田病院(群馬県)

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 04 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 Completed
Date of protocol fixation
2016 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 22 Day
Last follow-up date
2016 Year 03 Month 25 Day
Date of closure to data entry
2016 Year 04 Month 11 Day
Date trial data considered complete
2016 Year 04 Month 20 Day
Date analysis concluded
2016 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 04 Day
Last modified on
2016 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024060

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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