A clinical study to evaluate safety and effects of GLC-TC-ONS on blood glucose control

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011607

Enrollment

100

Registered

2026-02-12

Start date

2026-03-05

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

None listed

Interventions

Others : Two packs (400 ml/day) of test food (GLC-TC-ONS) or placebo (standard nutrition formula) will be consumed as breakfast daily for 8 weeks *Note: Under the current regulations of the Ministry o

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adults aged 30 to 70 years who have been diagnosed with early-stage type 2 diabetes mellitus (T2DM) (fasting blood glucose =126 mg/dL and <140 mg/dL, or HbA1c =6.5% and <7.0%)

Exclusion criteria

Exclusion criteria: 1) Patients with type 1 diabetes mellitus, or those with type 2 diabetes receiving antidiabetic medications (eligible if the dosage has remained unchanged), or those with heart failure or coronary artery disease requiring treatment, or with uncontrolled hypertension 2) Individuals taking medications that may affect body fat, lipid metabolism, or muscle function, or those who regularly consume of health functional foods or herbal medicines 3) Individuals with a body mass index (BMI) = 18.5 kg/m² or = 35 kg/m² 4) Individuals who habitually skip breakfast or have highly irregular eating patterns, excessive smokers, or those who regularly engage in high-intensity exercise. 5) Individuals who have participated in another clinical study within 1 month prior to the first visit and received an investigational drug or health functional food, or those planning to participate in another clinical study during the study period. 6) Pregnant or breastfeeding women, or individuals planning pregnancy during the study period 7) Individuals with hypersensitivity to any ingredient of the test or control food, or those with a history of severe food allergies.

Design outcomes

Primary

Measure	Time frame
blood glucose levels and related biomarkers	—

Secondary

Measure	Time frame
Safety assessments: Adverse events, vital signs, and clinical laboratory tests	—

Countries

Korea, Republic of

Contacts

Public ContactGa Hyun Lee

Yonsei University Health System, Severance Hospital

gahnlee@gmail.com+82-2-2228-2333

Outcome results