UMIN-CTR Clinical Trial

Basic information
Public title	Measurement of glycemic index (GI) of low GI foods
Acronym	Measurement of glycemic index (GI) of low GI foods
Scientific Title	Measurement of glycemic index (GI) of low GI foods
Scientific Title:Acronym	Measurement of glycemic index (GI) of low GI 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 glycemic index (GI) of three kind of low GI 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	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	3
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- wash out period (more than 1 day) - food-3, 120 min after consumption
Interventions/Control_2	50g OGTT, 120 min after consumption - wash out period (more than 1 day), 3 times - food-2, 120 min after consumption - wash out period (more than 1 day) - food-3, 120 min after consumption- wash out period (more than 1 day) - food-1, 120 min after consumption
Interventions/Control_3	50g OGTT, 120 min after consumption - wash out period (more than 1 day), 3 times - food-3, 120 min after consumption - wash out period (more than 1 day) - food-1, 120 min after consumption- wash out period (more than 1 day) - food-2, 120 min after consumption
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Males and females aged 20 to 65 years old. (2) Subjects whose blood glucose level is under 126 mg/dL. (3) 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 under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) (2)Subjects who suspected chronic or acute infectious disease. (3)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. (4) Subjects whose blood glucose level is under 70 mg/dL.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Naotaka Middle name Last name Kida
Organization	TableMark Company Limited
Division name	Research & Development Dept.
Zip code	144-0042
Address	5-14,Haneda Asahicho Ota-ku, Tokyo 144-0042, JAPAN
TEL	03-5705-7562
Email	naotaka.kida@tablemark.co.jp

Public contact
Name of contact person	1st name Mizuki Middle name Last name Hiranuma
Organization	TableMark Company Limited
Division name	Research & Development Dept.
Zip code	144-0042
Address	5-14,Haneda Asahicho Ota-ku, Tokyo 144-0042, JAPAN
TEL	03-5705-7562
Homepage URL
Email	mizuki.hiranuma@tablemark.co.jp

Sponsor
Institute	TableMark Company Limited
Institute
Department

Funding Source
Organization	TableMark Company Limited
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	TableMark Company Limited
Address	5-14,Haneda Asahicho Ota-ku, Tokyo 144-0042, JAPAN
Tel	03-5705-7562
Email	mizuki.hiranuma@tablemark.co.jp

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	2020 Year 08 Month 19 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2020 Year 08 Month 17 Day
Date of IRB	2020 Year 08 Month 18 Day
Anticipated trial start date	2020 Year 08 Month 24 Day
Last follow-up date	2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 19 Day
Last modified on	2021 Year 02 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047337