Human Clinical Trial Evaluating the Blood Glucose-Regulating Effects of Momordica Charantia Peptides

Inclusion criteria

• Adults aged 30-65 years, both male and female.
• Participants meeting any of the following criteria for prediabetes:

• Fasting blood glucose 100-125 mg/dL
• HbA1c 5.7-6.4%
• Previous clinical records indicating 2-hour OGTT glucose levels of 140-199 mg/dL
• Body mass index (BMI) between 24-35 kg/m², with waist circumference recorded (men ≥90 cm; women ≥80 cm).
• Stable lifestyle (including diet, physical activity, and sleep habits) during the past three months.
• No use of blood glucose-regulating supplements prior to or during the study.
• Willingness to comply with study procedures and complete all required assessments.
• Provision of written informed consent.

Exclusion criteria

• Diagnosis of type 2 diabetes mellitus (HbA1c ≥6.5% or physician diagnosis).
• Current use of antidiabetic medications (e.g., metformin, DPP-4 inhibitors, SGLT2 inhibitors, GLP-1 receptor agonists, or insulin).
• Use of medications that may affect blood glucose levels, such as corticosteroids, antipsychotic drugs, or unstable thyroid medications.
• Presence of severe hepatic, renal, cardiovascular diseases, active cancer, or gastrointestinal malabsorption disorders.
• Pregnant or breastfeeding women, or those planning to become pregnant.
• Body weight change exceeding ±5% within the past three months, or currently following a weight-loss program or special diet.
• History of alcohol abuse or substance misuse.
• Individuals engaged in night shift or rotating shift work.
• Known allergy to any component of the study product.
• Participation in another clinical trial within the past 1 month, or antibiotic use within the past 8 weeks (if gut microbiota analysis is involved).
• Individuals who are students currently taught by Associate Professor You-Cheng Shen or Dr. Jing-Bin Lin, or laboratory staff, assistants, or employees with a supervisory or subordinate relationship with the investigators.