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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029722
Receipt No. 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

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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
Email 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
Email mochizukik@yamanashi.ac.jp

Sponsor
Institute The Faculty of Life and Environmental Sciences, University of Yamanashi
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033951

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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