UMIN-CTR Clinical Trial

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

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to estimation of glycemic index of test foods.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Glycemic index
Key secondary outcomes	blood glucose AUC, postprandial blood glucose level, blood glucose Cmax, Glycemic index based on test food 3

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of Trelan-G50g- single intake of test food 1- single intake of test food 2- single intake of test food 3
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.Subjects aged from 20 to 50 years old
Key exclusion criteria	1. Subjects who have difficulty with blood sampling 2.Subjects whose blood glucose levels are more than 110 mg/dL 3.Subjects who have BMI more than 30 kg/m2 4. Subjects who have a history of diabetes or abnormal glucose tolerance. 5. Subjects who have a disease under medication or a history of a serious disease. 6. Subjects who have an allergy against test food. 7. Subjects who are judged as ineligible by principal investigator.
Target sample size	12

Research contact person
Name of lead principal investigator	Sayuri Matsuoka
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Email	matsuoka@fancl.co.jp

Public contact
Name of contact person	Yoshiki Shimizu
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3755
Homepage URL
Email	shimizu_yoshiki@fancl.co.jp

Sponsor
Institute	FANCL Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
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	2018 Year 01 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 12 Month 15 Day
Anticipated trial start date	2018 Year 01 Month 16 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	2018 Year 01 Month 12 Day
Last modified on	2018 Year 06 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035151