Exploratory study on the safety of yogurt ingestion and glycemic variability using FreeStyle Libre 2 in patients with type 2 diabetes

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 - Study on the effects of yogurt ingestion on safety and glycemic variability in patients with type 2 diabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000061238

Enrollment

Registered

2026-04-13

Start date

2026-04-14

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes

Interventions

Yogurt:Yes Yogurt:No

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactYuka Kobayashi

THE PHAGE, Inc. NA

yuka.kobayashi@thephage.life03-4500-1654

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026