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Not yet recruitingNCT07089732Updated Jul 28, 2025

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

An interventional study of GLP-1 formula liquid drink and Placebo in Obesity and Prediabetes, sponsored by Chung Shan Medical University. Not yet recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-28.

Sponsored by Chung Shan Medical University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Obesity
  • Prediabetes
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,695 are open to participants now.

This study's planned enrollment of 100 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    GLP-1 formula liquid drink

    GLP-1 formula liquid drink, 50 g/glass jar

    Dietary Supplement: GLP-1 formula liquid drink

  • Placebo comparator
    placebo

    The placebo contained the same base ingredients as the GLP-1 FORMULA but without the active GLP-1 FORMULA component.

    Dietary Supplement: Placebo

Interventions

  • Dietary supplementGLP-1 formula liquid drink

    One glass jar (50 g) of the GLP-1 formula liquid drink was administered once daily, 30 minutes prior to the first meal of the day.

  • Dietary supplementPlacebo

    One glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day.

06

What researchers measure

Primary outcomes

  1. Change from baseline in BMI at weeks 8 and 12

    Assessment of changes in BMI at baseline, week 8, and week 12

    Time frame: Week 0, 8 and 12

Secondary outcomes

  1. Change from baseline in blood glucose at weeks 8 and 12

    Assessment of blood glucose changes at weeks 0, 8, and 12

    Time frame: Week 0, 8 and 12

07

Study locations

1 site
  • Chung Shan Medical University
    Taichung, South 402 Recruiting, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07089732
Lead sponsor
Chung Shan Medical University
Responsible party
Sponsor
First posted
Jul 28, 2025
Start date
Aug 8, 2025 (estimated)
Primary completion
Apr 30, 2026 (estimated)
Completion
Jun 30, 2026 (estimated)
Last update
Jul 28, 2025

Study contacts

Chin-Lin Hsu Professor
Contact
clhsu@csmu.edu.tw
04-24730022 Ext. 12222

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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