Explore the Effect of Bitter Melon Peptides on Glycemic Control and Metabolic Indicators in Diabetic Patients

NCT06970834 | Not Yet Recruiting

• 1 other identifier: CCH IRB 250121
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn the potential of bitter melon peptides in stabilizing blood glucose in diabetic adults. It will also learn about the effects of bitter melon peptides on metabolic parameters. The main questions it aims to answer are:

• the regulatory effects of bitter melon peptides on glycemic variability
• impact on glycemic and metabolic indicators Researchers will compare bitter melon peptides to a placebo (a look-alike capsule that contains Microcrystalline Cellulose) to see if bitter melon peptides works to stabilizing blood glucose. Participants will:
• Take bitter melon peptides or a placebo every day for 12 weeks
• Visit the clinic on day 0, day 7, day 28 and day 84 for checkups and tests
• Glucose levels were monitored continuously by CGMs in the first 7 days and fasting blood samples were drawn at first visit (day0), third visit (day 28) and fourth visits (day 84)

Conditions

Diabetes

Keywords

bitter melon peptides

Outcome Measures

Primary Outcomes (1)

• glycemic variability

  mean amplitude of glucose excursions and coefficient of variation, using CGM

  From enrollment (day0) to day7

Secondary Outcomes (1)

• glycemic control

  From enrollment (day0) to the end (day84)

Other Outcomes (1)

• metabolic indicator

  From enrollment (day0) to the end (day84)

Study Arms (2)

bitter melon peptides

EXPERIMENTAL

Bitter melon peptide contains various active substances such as bitter melon saponins and bitter melon polysaccharides.

Dietary Supplement: bitter melon peptides

Placebo group

PLACEBO COMPARATOR

The placebo capsule containing microcrystalline cellulose. The placebo is identical in appearance, color, and dosage schedule to the intervention product, but does not contain any active ingredients.

Dietary Supplement: bitter melon peptides

Interventions

bitter melon peptides DIETARY_SUPPLEMENT

Momordica charantia extract

Placebo group; bitter melon peptides

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 6.5%, as measured on two separate occasions

Sponsors & Collaborators

• Changhua Christian Hospital: lead
• China Medical University, Taiwan: collaborator

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

PEI-YUNG LIAO, M.D.

CONTACT

+88647238595; 48795@cch.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Division of Endocrinology and Metabolism, Department of Internal Medicine

Model Details: A total of 160 diabetic patients on Metformin monotherapy will be recruited and randomized into either the bitter melon peptide group or the placebo group for a 12-week clinical intervention

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 14, 2025
• Study Start: May 27, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 26, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05