UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054094 |
|---|---|
| Receipt number | R000061770 |
| Scientific Title | Exploratory study of considering the effects of yogurt intake on measuring postprandial blood glucose level to use FreeStyle Libre |
| Date of disclosure of the study information | 2024/04/09 |
| Last modified on | 2024/05/01 11:53:19 |
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Basic information
Public title
Exploratory study of considering the effects of yogurt intake on measuring postprandial blood glucose level to use FreeStyle Libre
Acronym
Exploratory study of considering the effects of yogurt intake on measuring postprandial blood glucose level to use FreeStyle Libre
Scientific Title
Exploratory study of considering the effects of yogurt intake on measuring postprandial blood glucose level to use FreeStyle Libre
Scientific Title:Acronym
Exploratory study of considering the effects of yogurt intake on measuring postprandial blood glucose level to use FreeStyle Libre
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study is performed with blood glucose level data to be collected by FreeStyle Libre and related data, and consider the effects of postprandial blood glucose level data for yogurt intake at the beginning of breakfast.
In addition, blood glucose data obtained by Freestyle Libre will be analyzed to build a postprandial blood glucose waveform transition prediction model. Other acquired data will also be analyzed and used to construct a prediction model.
In addition, the accuracy of the prediction model will be improved.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change of postprandial blood glucose level between starting to intake on yogurt and completed the study (after 84 days).
Key secondary outcomes
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
Oral intake of yogurt at beginning of breakfast for 84 days.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Japanese healthy males and females over 18 years old
2) Being able to comply with the requirements and procedures of this study protocol
3) Giving written informed consent by subject for person
Key exclusion criteria
1) Having medical conditions need to care at medical hospital
2) Subjects with dairy allergies
3)Subjects who are judged as unsuitable for this study by the investigator for other reasons
Target sample size
330
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Tokunaga |
Organization
THE PHAGE, Inc.
Division name
NA
Zip code
150-0002
Address
5th Floor, Yamaguchi Building, 17-4 Shibuya 3-chome, Shibuya-ku, Tokyo, Japan
TEL
08057257759
tokunaga@thephage.life
Public contact
Name of contact person
| 1st name | Tokunaga |
| Middle name | |
| Last name | Shohei |
Organization
THE PHAGE, Inc.
Division name
NA
Zip code
150-0002
Address
5th Floor, Yamaguchi Building, 17-4 Shibuya 3-chome, Shibuya-ku, Tokyo, Japan
TEL
08057257759
Homepage URL
tokunaga@thephage.life
Sponsor or person
Institute
THE PHAGE, Inc.
Institute
Department
Personal name
Funding Source
Organization
THE PHAGE, Inc.
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
The Phage
Address
5th Floor, Yamaguchi Building, 17-4 Shibuya 3-chome, Shibuya-ku, Tokyo, Japan
Tel
08057257759
tokunaga@thephage.life
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
| 2024 | Year | 04 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 04 | Month | 08 | Day |
Last modified on
| 2024 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061770
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
