UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of barley bread intake on reducing postprandial glucose after consuming the second meals
Title of the study (Brief title)	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	Kazuki Mochizuki
Organization	University of Yamanashi
Division name	The Faculty of Life and Environmental Sciences
Address	4-4-37, Takeda, Kofu-shi, Yamanashi
TEL	055-220-8829
Email	mochizukik@yamanashi.ac.jp

Public contact
Name of contact person	Kazuki Mochizuki
Organization	University of Yamanashi
Division name	The Faculty of Life and Environmental Sciences
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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