ClinicalTrials.Veeva

Menu

Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals

C

Chung Shan Medical University

Status

Not yet enrolling

Conditions

Prediabetes
Obesity

Treatments

Dietary Supplement: GLP-1 formula liquid drink
Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT07089732
CS2-24199

Details and patient eligibility

About

A clinical human dietary intervention trial was conducted to investigate the effects of GLP-1 FORMUL liquid supplementation in individuals with prediabetes or obesity, with a focus on improvements in glycemic and lipid parameters, body composition, and gut microbiota profiles.

Full description

This 12-week randomized, placebo-controlled clinical trial aims to evaluate the nutritional and metabolic effects of GLP-1 FORMULA liquid supplementation. A total of 100 adult participants will be recruited and randomly assigned to one of two groups: (1) placebo group (n = 50), and (2) GLP-1 FORMULA group (n = 50). Participants will consume one bottle (50 g) of either GLP-1 FORMULA or placebo 30 minutes prior to their first meal each day for 8 weeks, followed by a 4-week post-intervention observation period.

Throughout the study, participants will undergo nutritional assessments including body composition analysis, waist-to-hip ratio measurements, appetite rating scales, gastrointestinal symptom questionnaires, and the Patient Health Questionnaire. Additionally, oral glucose tolerance tests (OGTT), standard blood biochemistry analyses, and fecal sample collection will be conducted at designated time points to evaluate glycemic control, metabolic markers, and gut microbiota composition.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Adults aged 18 to 70 years.
  • Clinically diagnosed with prediabetes (fasting plasma glucose: 100-125 mg/dL or HbA1c: 5.7-6.4%) or with a body mass index (BMI) of 25-34.9 kg/m², male or female.
  • Have not participated in similar clinical studies within the past three months.
  • Able to comprehend the informed consent form, including the study procedures, potential risks, and benefits, and able to provide written informed consent.

Exclusion criteria

  • Diagnosed with autoimmune diseases or cancer.
  • Diagnosed with gastrointestinal chronic diseases such as irritable bowel syndrome, inflammatory bowel disease, Crohn's disease, celiac disease, bowel control disorders, fecal incontinence, pancreatitis, peptic ulcer disease, colorectal cancer, short bowel syndrome, ulcerative colitis, lactose intolerance, or chronic diarrhea.
  • History of gastrointestinal surgery.
  • Planning pregnancy in the near future (including male partners), currently pregnant, or breastfeeding women.
  • Known allergy or hypersensitivity to probiotics or any of the study product ingredients.
  • History of major psychiatric disorders.
  • History of substance abuse or alcohol dependency.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

100 participants in 2 patient groups, including a placebo group

GLP-1 formula liquid drink
Experimental group
Description:
GLP-1 formula liquid drink, 50 g/glass jar
Treatment:
Dietary Supplement: GLP-1 formula liquid drink
placebo
Placebo Comparator group
Description:
The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component.
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

Loading...

Central trial contact

Chin-Lin Hsu Professor

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems