UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062229 |
|---|---|
| Receipt number | R000071184 |
| Scientific Title | Exploratory study on long-term yogurt ingestion and glycemic variability in local residents of Fukui Prefecture: A non-ingestion controlled randomized trial using FreeStyle Libre 2 |
| Date of disclosure of the study information | 2026/07/14 |
| Last modified on | 2026/07/14 10:26:08 |
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Basic information
Public title
Exploratory study on long-term yogurt ingestion and glycemic variability in local residents of Fukui Prefecture
Acronym
Study on the effects of long-term yogurt ingestion on glycemic variability in local residents of Fukui Prefecture
Scientific Title
Exploratory study on long-term yogurt ingestion and glycemic variability in local residents of Fukui Prefecture: A non-ingestion controlled randomized trial using FreeStyle Libre 2
Scientific Title:Acronym
Study on the effects of long-term yogurt ingestion on glycemic variability in local residents
Region
| Japan |
Condition
Condition
Prediabetes (Individuals at high risk for type 2 diabetes)
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to exploratorily evaluate the suppressive effect of long-term (12-week) ingestion of yogurt containing MI-2 lactic acid bacteria on postprandial glucose spikes in local residents with prediabetes who are at high risk for type 2 diabetes. Utilizing the FreeStyle Libre 2 system and a dietary management app (glucose flight), we will clarify the detailed changes in glycemic dynamics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic variability from screening/baseline (-2 weeks) to V3 (12 weeks) measured by FreeStyle Libre 2 indices (Mean Glucose, Standard Deviation, AC_Var).
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of yogurt for 12 weeks
Interventions/Control_2
No treatment
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 men and women aged 18 years or older.
2. Individuals with an HbA1c level between 5.6% and 6.4% within one year prior to obtaining informed consent.
3. Residents of Fukui Prefecture or neighboring areas who can regularly visit the designated medical institution.
4. Individuals who own a smartphone and can appropriately install and operate the designated apps (glucose flight, LibreLink, etc.) and record/take photos of meals.
Key exclusion criteria
1. Individuals already diagnosed with diabetes and using diabetes medications (oral hypoglycemic agents, GLP-1 receptor agonists, insulin, etc.).
2. Individuals who regularly consume health foods, supplements, Foods for Specified Health Uses (FOSHU), or Foods with Function Claims that claim to lower or maintain blood glucose levels and who are unable to discontinue their use during the study period (from screening to the end of the study).
3. Women who are pregnant, lactating, or may be pregnant.
4. Patients with severe hepatic or renal disease.
5. Individuals with a milk allergy, a history of lactose intolerance, or otherwise considered unsuitable for yogurt consumption.
6. Individuals who plan to remove the FreeStyle Libre 2 sensor during the study period (e.g., for health checkups), or who are judged to have difficulty maintaining compliance during the study period.
7. Others judged inappropriate by the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Masuyama |
Organization
THE PHAGE, Inc.
Division name
NA
Zip code
150-0002
Address
VEIL SHIBUYA 2F, 2-16-8 Shibuya, Shibuya-ku, Tokyo 150-0002, Japan
TEL
03-4500-1654
masuyama@thephage.life
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Iwasa |
Organization
THE PHAGE, Inc.
Division name
NA
Zip code
150-0002
Address
VEIL SHIBUYA 2F, 2-16-8 Shibuya, Shibuya-ku, Tokyo 150-0002, Japan
TEL
03-4500-1654
Homepage URL
kosuke.iwasa@thephage.life
Sponsor or person
Institute
THE PHAGE, Inc.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
THE PHAGE, Inc. Ethics Committee
Address
VEIL SHIBUYA 2F, 2-16-8 Shibuya, Shibuya-ku, Tokyo
Tel
070-4813-6517
kotaro.fujino@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
| 2026 | Year | 07 | Month | 14 | 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
| 2026 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 07 | Month | 14 | Day |
Last modified on
| 2026 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071184
