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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-65
SponsorChung Shan Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 30-65 years, both male and female.

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • BmpP® Momordica charantia Peptide Capsules

    Dietary supplement

    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.

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Bitter Melon Peptide SupplementationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Week 0) and Week 12
2

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.

Time frame
Baseline (Week 0) and Week 12
3

Glycated Hemoglobin (HbA1c)

HbA1c levels will be measured to evaluate long-term glycemic control after supplementation with bitter melon peptide capsules.

Time frame
Baseline (Week 0) and Week 12

Secondary outcomes

Other outcomes

Sponsors and contacts

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