UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018812 |
|---|---|
| Receipt number | R000021762 |
| Scientific Title | Measurement of glycemic index (GI) of low GI foods |
| Date of disclosure of the study information | 2015/08/26 |
| Last modified on | 2016/01/27 14:32:34 |
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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 each glycemic index (GI) of two 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
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 | Katsuhisa Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
k.s@cpcc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
m.i@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
TableMark Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 08 | Month | 26 | 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
| 2015 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 26 | 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
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021762
