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

Prediabetes is a metabolic condition characterized by elevated blood glucose levels that are higher than normal but below the diagnostic threshold for diabetes. Early intervention to improve glycemic control may help delay the progression to type 2 diabetes. Momordica charantia (bitter melon) peptides have been reported to possess potential glucose-regulating effects.

This study aims to evaluate the effects of BmpP® bitter melon peptide supplementation on glycemic control in adults with prediabetes. This study is designed as a 12-week single-arm, open-label clinical trial. Approximately 12 adults aged 30-65 years with prediabetes will be recruited. Participants will consume bitter melon peptide capsules three times daily before meals for 12 weeks.

Primary outcomes include fasting blood glucose, postprandial glucose response, and HbA1c levels. The findings of this study may provide preliminary evidence regarding the potential role of bitter melon peptides in blood glucose regulation.

Study Overview

• Status: Recruiting
• Conditions: People With Prediabetic
• Intervention / Treatment: Dietary supplement: BmpP® Momordica charantia Peptide Capsules

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan
    • Recruiting
    • Chung Shan Medical University
    • Contact: You-Cheng Mr Shen, Ph.D.; Phone Number: 11868 886-4-24730022; Email: youcheng@csmu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bitter Melon Peptide Supplementation; Participants with prediabetes will receive BmpP® bitter melon peptide capsules three times daily before meals for 12 weeks. Study visits will be conducted at baseline (week 0), week 6, and week 12 for clinical assessments.	Dietary supplement: BmpP® Momordica charantia Peptide Capsules; Participants will consume one capsule of BmpP® bitter melon peptide before each meal (three capsules per day) with approximately 200 mL of water for 12 weeks. Blood glucose levels, HbA1c, and other metabolic parameters will be evaluated through blood sampling and oral glucose tolerance tests (OGTT) at baseline and week 12.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-hour Glucose Area Under the Curve (2h-gluAUC)	Blood glucose levels will be measured during a 2-hour oral glucose tolerance test (OGTT) at 0, 15, 30, 45, 60, 90, and 120 minutes after ingestion of a 75 g glucose solution. The area under the glucose curve will be calculated to evaluate postprandial glycemic response.	Baseline (Week 0) and Week 12
Maximum Incremental Blood Glucose (maxΔBG)	The maximum increase in blood glucose concentration following glucose ingestion during the OGTT will be calculated as the difference between the highest glucose level and the baseline fasting glucose level.	Baseline (Week 0) and Week 12
Glycated Hemoglobin (HbA1c)	HbA1c levels will be measured to evaluate long-term glycemic control after supplementation with bitter melon peptide capsules.	Baseline (Week 0) and Week 12

Collaborators and Investigators

• Sponsor: Chung Shan Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: March 25, 2026
• First Submitted That Met QC Criteria: March 25, 2026
• First Posted (Actual): March 31, 2026

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CS1-25192

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No