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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-64
SponsorHuazhong University of Science and Technology

About this trial

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 criteria

Qualifiers

Obesity: BMI >=28 kg/m²;

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • inulin (prebiotics)
  • Placebo Comparator: maltodextrin

Treatment groups

600 Participants
are divided into 2 treatment groups