UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061238 |
|---|---|
| Receipt number | R000070066 |
| Scientific Title | Exploratory study on the safety of yogurt ingestion and glycemic variability using FreeStyle Libre 2 in patients with type 2 diabetes: a randomized,non-ingestion controlled trial |
| Date of disclosure of the study information | 2026/04/13 |
| Last modified on | 2026/04/12 20:44:59 |
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Basic information
Public title
Exploratory study on the safety of yogurt ingestion and glycemic variability using FreeStyle Libre 2 in patients with type 2 diabetes
Acronym
Study on the effects of yogurt ingestion on safety and glycemic variability in patients with type 2 diabetes
Scientific Title
Exploratory study on the safety of yogurt ingestion and glycemic variability using FreeStyle Libre 2 in patients with type 2 diabetes: a randomized,non-ingestion controlled trial
Scientific Title:Acronym
Study on the effects of yogurt ingestion on safety and glycemic variability in patients with type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the safety and the effects on glycemic variability of long-term (12-week) ingestion of yogurt in patients with type 2 diabetes receiving standard treatment (metformin). Utilizing the FreeStyle Libre 2 system and a dietary management app, we will exploratorily evaluate effects such as the suppression of postprandial glucose spikes, while confirming safety aspects including the risk of hypoglycemia and the impact on hepatic and renal functions under concomitant use of metformin.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety assessment: Clinically significant changes in blood biochemical tests, including liver function (AST, ALT, gamma-GTP), renal function (Cr, eGFR), and glucose metabolism (HbA1c, GA, HOMA-IR).
Key secondary outcomes
1.Changes in glycemic variability parameters measured by FreeStyle Libre 2 (TIR, TAR, TBR, Mean Glucose, MAGE, CV, GMI, IAUC, Cmax, dCmax, Tmax, dTmax, AC_Mean, and AC_Var) from the non-ingestion period (baseline) to the 12-week ingestion period.
2.Changes in inflammatory markers (hs-CRP, IL-6, IL-10) as exploratory outco
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
Yogurt:Yes
Interventions/Control_2
Yogurt:No
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
| 35 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Japanese patients with type 2 diabetes aged 35 years or older (regardless of sex).
2.Patients taking metformin (including combination drugs).
3.Patients with HbA1c < 8.0%.
4.Patients who own a smartphone.
Key exclusion criteria
1.Women who are pregnant, breastfeeding, or may be pregnant.
2.Patients with severe hepatic or renal diseases.
3.Patients with a milk allergy.
4.Patients who are judged to have difficulty maintaining compliance during the study period.
5.Patients using implantable medical devices such as pacemakers.
6.Patients who plan to remove the FreeStyle Libre 2 sensor during the study period (e.g., for health checkups).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Masuyama |
Organization
Nishidai Ekimae Masuyama Internal Medicine and Diabetes Clinic
Division name
NA
Zip code
175-0082
Address
4FM-OneBldg.,1-79-3 Takashimadaira, Itabashi-ku, Tokyo
TEL
03-6906-6971
atudigi@gmail.com
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Kobayashi |
Organization
THE PHAGE, Inc.
Division name
NA
Zip code
150-0002
Address
VEIL SHIBUYA 2F, 2-16-8 Shibuya, Shibuya-ku, Tokyo
TEL
03-4500-1654
Homepage URL
yuka.kobayashi@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 | 04 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 19 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 04 | Month | 12 | Day |
Last modified on
| 2026 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070066
