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

NCT ID: NCT06970834

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-27

Study Completion Date

2026-03-26

Brief Summary

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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)

Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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bitter melon peptides

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

Group Type EXPERIMENTAL

bitter melon peptides

Intervention Type DIETARY_SUPPLEMENT

Momordica charantia extract

Placebo group

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.

Group Type PLACEBO_COMPARATOR

bitter melon peptides

Intervention Type DIETARY_SUPPLEMENT

Momordica charantia extract

Interventions

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bitter melon peptides

Momordica charantia extract

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

≥ 6.5%, as measured on two separate occasions
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, Taiwan

OTHER

Sponsor Role collaborator

Changhua Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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PEI-YUNG LIAO

Chief of Division of Endocrinology and Metabolism, Department of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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PEI-YUNG LIAO, M.D.

Role: CONTACT

+88647238595

Other Identifiers

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CCH IRB 250121

Identifier Type: -

Identifier Source: org_study_id

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