UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of glycemic index (GI) of foods
Title of the study (Brief title)	Measurement of glycemic index (GI) of foods
Region	Japan

Condition
Condition	Nothing (Healthy subjects)
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Measurement of each glycemic index (GI) of two kind of foods
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic index (GI) 120 min after consumption
Key secondary outcomes	Incremental blood glucose area under the curve 120 min after consumption

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	50g OGTT, 120 min after consumption - wash out period (more than 1 day), 3 times - food-1, 120 min after consumption - wash out period (more than 1 day) - food-2, 120 min after consumption
Interventions/Control_2
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Males and females aged 20 to 50 years old. (2)Healthy subjects (3)Subjects whose body mass index (BMI) is under 30kg/m2 (4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria	(1)Subjects who have severe disease history. (2)Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver function, kidney function and cardiovascular system. (3)Subjects who have previous medical history of food and/or drug allergy. (4)Subjects who suspected chronic or acute infectious disease. (5)Subjects who commonly used antihypertensive agents. (6) Subjects who donated 200 mL of blood within a month, or donated over 400 mL of blood within the last three month, to the current study. (7) Subjects who impaired glucose tolerance. (8)Females whose menstrual period include test day. (9) Subjects who participated the other clinical test within 1 month before test start. (10)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
Target sample size	10

Research contact person
Name of lead principal investigator	Naotaka Kida
Organization	TableMark Company Limited
Division name	Research & Development Dept.
Address	5-14,Haneda Asahicho Ota-ku, Tokyo 144-0042, JAPAN
TEL	03-5705-7515
Email	naotaka.kida@tablemark.co.jp

Public contact
Name of contact person	Hiroki Morishima
Organization	TableMark Company Limited
Division name	Research & Development Dept.
Address	5-14,Haneda Asahicho Ota-ku, Tokyo 144-0042, JAPAN
TEL	03-5705-7515
Homepage URL
Email	hiroki.morishima@tablemark.co.jp

Sponsor
Institute	TableMark Company Limited
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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 01 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 05 Day
Anticipated trial start date	2017 Year 01 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 01 Month 05 Day
Last modified on	2017 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029402