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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024183
Receipt No. R000027841
Scientific Title Effects of barley bread intake on reducing postprandial glucose after consuming the second meals
Date of disclosure of the study information 2016/10/05
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 Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation
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 with salmon and corn potage soup (150-200g) 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 with salmon and corn potage soup (150-200g) 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) 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 25

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 The Faculty of Life and Environmental Sciences, 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
2016 Year 10 Month 05 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The blood glucose concentration at 120 min after the first meal intake and the AUC were lower at the barley bread intake than at the wheat bread intake. In addition, a tendency to decrease of the blood glucose concentration by the barley bread intake was found at 60 and 90 min. However, no differences between the two groups was observed in blood glucose concentrations after the second meal 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
2016 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 05 Day
Last follow-up date
2016 Year 12 Month 30 Day
Date of closure to data entry
2017 Year 01 Month 20 Day
Date trial data considered complete
2017 Year 01 Month 20 Day
Date analysis concluded
2017 Year 01 Month 20 Day

Other
Other related information The Japanese Society for Food Science and Technology. Kanto Regional Competition(H29)

Management information
Registered date
2016 Year 09 Month 27 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=R000027841

Research Plan
Registered date File name
2018/05/21 日本食品科学工学会関東支部会_大麦パンセカンドミール201703.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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