UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021766 |
|---|---|
| Receipt number | 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 15:33:58 |
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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's University
Division name
Faculty of Home Economics
Zip code
Address
12 Sanban-cho, Chiyoda-ku, Tokyo 102-8357, Japan
TEL
03-5275-6048
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
n-kamata@gunei-chemical.co.jp
Sponsor or person
Institute
GUN EI Chemical Industry CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024060
