Clinical trial

Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA ) Medications for Weight Loss

Opening soon · Not applicable · 1 countries · Registry ID NCT07611552

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity & Overweight

Full registry criteria

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.

Treatments and study arms

inulin (prebiotics)

Dietary Supplement

The intervention dose is 10 grams per day. The intervention will last for 4 months.

Placebo Comparator: maltodextrin

Dietary Supplement

The dose is 10 grams per day for 4 months.

Primary outcomes

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.

Study locations

5 locations were listed when this page was built. The first 40 are shown.

The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture🇨🇳 Enshi, Hubei, China
Sinopharm Dongfeng General Hospital🇨🇳 Shiyan, Hubei, China
Huazhong University of Science and Technology🇨🇳 Wuhan, Hubei, China
Yuxia Wei, PhDContact
An Pan, PhDContact
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology🇨🇳 Wuhan, Hubei, China
Xiangyang No.1 People's Hospital🇨🇳 Xiangyang, Hubei, China