UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025545
Receipt No. R000029402
Scientific Title Measurement of glycemic index (GI) of foods
Date of disclosure of the study information 2017/01/10
Last modified on 2017/08/15

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Measurement of glycemic index (GI) of foods
Acronym Measurement of glycemic index (GI) of foods
Scientific Title Measurement of glycemic index (GI) of foods
Scientific Title:Acronym 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
1st name
Middle name
Last name Naotaka Kida
Organization TableMark Company Limited
Division name Research & Development Dept.
Zip code
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
1st name
Middle name
Last name Hiroki Morishima
Organization TableMark Company Limited
Division name Research & Development Dept.
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2017 Year 01 Month 05 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000029402

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.