UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030784 |
|---|---|
| Receipt number | R000035151 |
| Scientific Title | Estimation of glycemic index of test foods |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2018/06/22 09:40:28 |
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Basic information
Public title
Estimation of glycemic index of test foods
Acronym
Estimation of glycemic index of test foods
Scientific Title
Estimation of glycemic index of test foods
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Sayuri Matsuoka |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
matsuoka@fancl.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Shimizu |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
Address
12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
Homepage URL
shimizu_yoshiki@fancl.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
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)
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
| 2018 | Year | 01 | Month | 15 | 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 | 12 | Month | 15 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035151
