UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Determination of glycemic index (GI) of bread
Title of the study (Brief title)	Determination of glycemic index (GI) of bread.
Region	Japan

Condition
Condition	Healthy subjects
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Determination of glycemic index (GI) of bread.
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic index(GI)
Key secondary outcomes	Postprandial blood glucose level, Postprandial maximum blood glucose level, Incremental blood glucose area under the curve GI; Subjects with fasting plasma glucose <100 mg/dL, and =>100 mg/dL, respectively.

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 (50g/150ml) wash out period (at least 5 days) bread A wash out period (at least 5 days) bread B
Interventions/Control_2	Glucose solution as reference (50g/150ml) wash out period (at least 5 days) bread B wash out period (at least 5 days) bread A
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	51 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Aged between 20 and 50 years old at consent. (2) Fasting plasma glucose 70-126mg/dl (3) Subjects whose body mass index (BMI) is under 30kg/m2 (4) Subjects who understand the study procedures and agree to participate in the study by giving informed consent prior to the study.
Key exclusion criteria	1) Subjects who have history of malignant diseases. 2) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, organ). 3) Subjects who have previous medical history of drug and/or food allergy. 4) Subjects who have infectious diseases. 5) Subjects who have continuous intake of medicine and/or health food for carbohydrate metabolism 6) Subjects who donated over 200 mL blood within the last one month, and/or over 400 mL blood within the last three month. 7) Subjects with impaired glucose tolerance. 8) Subjects who is menstruating in this clinical test. 9) Females who are pregnant or lactating, and who could become pregnant or lactating during test period. 10) Subjects who plan to participate in other clinical tests. 11) Subjects who are not eligible for this study for some medical reasons.
Target sample size	26

Research contact person
Name of lead principal investigator	Katsuhisa Sakano
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Email	k.s@cpcc.co.jp

Public contact
Name of contact person	Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
Address	4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan
TEL	03-5297-3112
Homepage URL
Email	m.i@cpcc.co.jp

Sponsor
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Nisshin Seifun Group Inc.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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 02 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 19 Day
Anticipated trial start date	2017 Year 02 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 02 Month 09 Day
Last modified on	2017 Year 08 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029951