Bitter melon peptide effects on blood sugar in people with prediabetes

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

This 12-week test will see if taking bitter melon (Momordica charantia) peptide capsules three times daily before meals can improve blood sugar control in adults with prediabetes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Chung Shan Medical University (Academic / other)
• Locations: 1 site (Taichung)
• Trial ID: NCT07504029 on ClinicalTrials.gov

What this trial studies

This is a 12-week, single-arm, open-label trial enrolling about 12 adults aged 30–65 with prediabetes to receive BmpP® bitter melon peptide capsules three times daily before meals. Participants will have fasting blood glucose, postprandial glucose responses, and HbA1c measured at baseline and during follow-up to track glycemic changes. The trial excludes people with diagnosed type 2 diabetes, those on antidiabetic medications, or those using supplements/medications that affect glucose. Findings will provide preliminary human data on whether this specific bitter melon peptide formulation influences short-term glycemic markers.

Who should consider this trial

Good fit: Adults aged 30–65 with prediabetes (fasting glucose 100–125 mg/dL, HbA1c 5.7–6.4%, or 2-hour OGTT 140–199 mg/dL), BMI 24–35 kg/m², stable lifestyle habits, and willingness to take capsules three times daily are ideal candidates.

Not a fit: People with established type 2 diabetes, those taking antidiabetic drugs or other medications that affect blood glucose, or those outside the specified BMI or age ranges are unlikely to benefit from or qualify for this protocol.

Why it matters

Potential benefit: If successful, the supplement could offer a simple oral approach to help lower fasting and postprandial glucose and potentially delay progression to type 2 diabetes.

How similar studies have performed: Animal studies and small human trials of bitter melon extracts have suggested possible glucose-lowering effects, but human evidence is limited and results have been mixed.

Eligibility criteria

Inclusion Criteria:

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

  1. Fasting blood glucose 100-125 mg/dL
  2. HbA1c 5.7-6.4%
  3. 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.

Where this trial is running

Taichung

• Chung Shan Medical University — Taichung, Taiwan (Recruiting)

Conditions People With Prediabetic