UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029722 |
|---|---|
| Receipt number | R000033951 |
| Scientific Title | Effects of barley bread intake on reducing postprandial glucose after consuming the second meals |
| Date of disclosure of the study information | 2017/10/29 |
| Last modified on | 2018/05/21 11:08:47 |
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Basic information
Public title
Effects of barley bread intake on reducing postprandial glucose after consuming the second meals
Acronym
Second meal effects of barley bread intake
Scientific Title
Effects of barley bread intake on reducing postprandial glucose after consuming the second meals
Scientific Title:Acronym
Second meal effects of barley bread intake
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we examine second meal effects of barley bread, by measuring blood glucose concentrations just before and after consuming barley bread or wheat bread at breakfast (first meal), and just before and after consuming a common test meal at lunch (second meal).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
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
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects consume barley bread (50g carbohydrate amount) and approximately 180 mL milk at breakfast (first meal). The subjects consume 3 rice balls at lunch (second meal).
The blood concentrations of glucose are measured just before and 15-120 min after consuming first and second meals.
Interventions/Control_2
The subjects consume wheat bread (50g carbohydrate amount) and approximately 180 mL milk at breakfast (first meal). The subjects consume 3 rice balls at lunch (second meal).
The blood concentrations of glucose are measured just before and 15-120 min after consuming first and second meals.
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy subjects met criteria as follows
(1) Students at the University of Yanamashi
(2) Employees in Hakubaku co.,Ltd
(3) Age 20 or over and below the age of 30
Key exclusion criteria
Exclusion criteria is as follows:
(1) Subjects diagnosed as metabolic diseases such as diabetes, hypertension, hyperlipidemia and hyperuricemia
(2) Subjects diagnosed as impaired glucose tolerance in the past year
(3) Subjects with severe infective diseases, with severe diseases such as cancer, with severe external injuries, or/and just before and just after operations.
(4) Subjects consuming anti-diabetic drugs out of National Health Insurance
(5) Subjects consuming routinely health foods such as supplements, which speculatively affect the results of the trial
(6) Smokers
(7) Subjects with excessive alcohol drinking
(8) Subjects with hypersensitiveness for test foods (e.g. alimentary allergies) in the trial
(9) Subjects with pregnancy or possibility of pregnancy
(10) Subjects found offensive by doctors, health nurse and persons responsible to the trial
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki Mochizuki |
Organization
University of Yamanashi
Division name
The Faculty of Life and Environmental Sciences
Zip code
Address
4-4-37, Takeda, Kofu-shi, Yamanashi
TEL
055-220-8829
mochizukik@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuki Mochizuki |
Organization
University of Yamanashi
Division name
The Faculty of Life and Environmental Sciences
Zip code
Address
4-4-37, Takeda, Kofu-shi, Yamanashi
TEL
055-220-8829
Homepage URL
mochizukik@yamanashi.ac.jp
Sponsor or person
Institute
The Faculty of Life and Environmental Sciences, University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
University of Yamanashi
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hakubaku. Co., Ltd.
University of Shizuoka
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 29 | 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
In analysis excluded 6 subjects with greater or equal to criteria of borderline diabetes (fasting blood glucose of 110 mg / dL), the blood glucose concentration at 90 minutes after the second meal intake was significantly lower at the barley bread intake in the first meal than at the wheat bread intake (p<0.05). Analysis of all participants showed that the blood glucose concentrations at 30 min after the first meal intake and at 60 and 90 min after the second meal intake (p<0.05) were significantly lower at the barley bread intake than at the wheat bread intake.
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
| 2017 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 20 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 20 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 26 | Day |
Last modified on
| 2018 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033951
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| Registered date | File name |
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