Effects of a GLP-1 Formula Drink on Gut Microbiota and Glycemic Control in Prediabetic Individuals
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorChung Shan Medical University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
GLP-1 formula liquid drink
Dietary supplementOne 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.
Placebo
Dietary supplementOne glass jar (50 g) of the placebo liquid drink was administered once daily, 30 minutes prior to the first meal of the day.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: GLP-1 formula liquid drinkExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
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 12Secondary 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 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: