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.
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.
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;
Parallel
inulin (prebiotics)
Dietary supplementThe intervention dose is 10 grams per day. The intervention will last for 4 months.
Placebo Comparator: maltodextrin
Dietary supplementThe dose is 10 grams per day for 4 months.
change in concentrations of blood lipid levels in millimole per liter (mmol/L).
change in total cholesterol and triglycerides levels from baseline to 4-month visit. The values will be reported in mmol/L.
change in frequency of gastrointestinal symptoms
change in frequency of gastrointestinal symptoms such as diarrhea and constipation baseline to 4-month visit
change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol)
Description: change in concentration of glycosylated Hemoglobin A1c (HbA1c) from baseline to 4-month visit. The values will be reported in mmol/mol.
change in level of insulin resistance
Change in HOMA-IR (homeostatic model assessment of insulin resistance) and adipo-IR (adipose tissue insulin resistance index) from baseline to 4-month visit. HOMA-IR will be calculated based on fasting glucose (mmol/L) and fasting insulin (mIU/L). Adipo-IR will be estimated using fasting insulin (mIU/L) and fasting free fatty acids (mmol/L).
change in body weight in kilograms (kg)
Change in body weight (kg) from baseline to 4-month visit
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