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

Changhua Christian Medical Foundation

Status: Not yet enrolling

Conditions: Diabetes

Treatments: Dietary Supplement: bitter melon peptides

Study type: Interventional

Funder types: Other

Identifiers

NCT06970834

CCH IRB 250121

Details and patient eligibility

About

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)

Enrollment: 160 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:Participants were diagnosed with type 2 DM based on criteria recommended by the American Diabetes Association and required to have fasting plasma glucose of ≥126 mg/dl or an HbA1c of

≥ 6.5%, as measured on two separate occasions

Exclusion Criteria:cancer, active liver disease, current pregnancy , acute illness and autoimmune thyroid disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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160 participants in 2 patient groups, including a placebo group

bitter melon peptides

Experimental group

Description:

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

Treatment:

Dietary Supplement: bitter melon peptides

Placebo group

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: bitter melon peptides