Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA ) Medications for Weight Loss
inulin (prebiotics): The intervention dose is 10 grams per day. The intervention will last for 4 months.
Placebo Comparator: maltodextrin: The dose is 10 grams per day for 4 months.
Study summary
The goal of this double-blind randomized placebo-controlled supplement study is to investigate if the supplement of inulin (prebiotics, 10 grams per day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving glucagon-like peptide-1 receptor agonists (GLP-1 RA) medications for weight loss.
Eligibility
Sex
ALL
Min age
18 Years
Max age
64 Years
Healthy volunteers
No
Inclusion criteria:
* Be overweight or obese (meeting any of the following criteria):
1. Obesity: BMI \>=28 kg/m²;
2. Overweight (BMI \>= 24 kg/m²) with at least one body weight-related comorbidity: obstructive sleep apnea syndrome, prediabetes, type 2 diabetes mellitus, hypertension, dyslipidemia, polycystic ovary syndrome, or non-alcoholic fatty liver disease.
* Must have received GLP-1 RA drugs (Semaglutide, Liraglutide, Benaglutide, Tirzepatide, or Mazdutide) for weight-loss intervention for at least 3 months, and plan to continue using them for the next six months.
* Age 18-64 years.
* Consent to participate and sign the informed consent form.
Exclusion criteria:
* Currently using non-GLP-1 RA medications for weight-loss, or have undergone or plan to undergo weight-loss procedures within the next 4 months;
* Long-term user of prebiotics or probiotics (excluding fermented dairy products such as yogurt);
* Be allergic or intolerance to inulin-type substances;
* Have participated in in other clinical trials within the past 3 months or are currently participating in other clinical trials;
* Plan to be pregnant within the next year, are currently pregnant, or are breastfeeding;
* Deemed unsuitable for participation by the investigator's judgment.
Primary outcome measure(s)
change in concentrations of blood lipid levels in millimole per liter (mmol/L). — From enrollment to the end of intervention at 4 months change in total cholesterol and triglycerides levels from baseline to 4-month visit. The values will be reported in mmol/L.
Trial sites (5)
Facility
City
Region
Status
The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
Enshi
Hubei
Sinopharm Dongfeng General Hospital
Shiyan
Hubei
Huazhong University of Science and Technology
Wuhan
Hubei
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Xiangyang No.1 People's Hospital
Xiangyang
Hubei
More Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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