Obesity & Overweight
Conditions
Keywords
weight loss, cardiometabolic risk factors, prebiotics, lipids, glucagon-like peptide-1 receptor agonists (GLP-1 RA)
Brief 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.
Detailed description
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. Approximately 600 overweight or obese individuals using GLP-1 RA medications for weight loss will be enrolled. All participants will provide informed consent before randomization. Eligible individuals must be obese or be overweight with at least one body weight-related complications, and have been using GLP-1 RA medications at the time of enrollment for at least 3 months and plan to continue using them in the next 6 months. Eligible participants will be randomly assigned to inulin intervention or placebo group. Randomization will be computed within study center, age and sex groups. The intervention will last for 4 months. Questionnaire data and bio-samples will be collected before the start of intervention and at the end of the intervention. The primary outcomes are lipid levels measured in bio-samples. Data on secondary outcomes will be obtained through biomarker measurement and questionnaires.
Interventions
DIETARY_SUPPLEMENTinulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
DIETARY_SUPPLEMENTPlacebo Comparator: maltodextrin
The dose is 10 grams per day for 4 months.
Sponsors
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in frequency of gastrointestinal symptoms | From enrollment to the end of intervention at 4 months | 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) | From enrollment to the end of intervention at 4 months | 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 | From enrollment to the end of intervention at 4 months | 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) | From enrollment to the end of intervention at 4 months | Change in body weight (kg) from baseline to 4-month visit |
| change in body fat percentage (%) | From enrollment to the end of intervention at 4 months | change in body fat percentage from baseline to 4-month visit. The values will be reported in percentage (%). |
| change in waist circumference in centimeters (cm) | From enrollment to the end of intervention at 4 months | Change in waist Circumference (cm) from baseline to the 4-month visit. |
| change in level of gut microbiota abundance | From enrollment to the end of intervention at 4 months | Change in gut microbiota abundance from baseline to 4-month visit |
| change in level of gut microbiota diversity | From enrollment to the end of intervention at 4 months | Change in gut microbiota alpha and beta diversity from baseline to 4-month visit. |
| change in estimated glomerular filtration rate (eGFR) in milliliter per minute per 1.73 square meters (mL/min/1.73 m²) | From enrollment to the end of intervention at 4 months | Change in estimated glomerular filtration rate (eGFR) from baseline to the 4-month visit. The Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI ) (2009) method will be used to estimate eGFR value. The value is reported in milliliter per minute per 1.73 square meters (mL/min/1.73 m²). |
| change in concentrations of liver function markers in units per liter (U/L) | From enrollment to the end of intervention at 4 months | Change in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) from baseline to the 4-month visit. These values are reported in units per liter (U/L). |
| change in level of C-reactive protein (CRP) in milligram per liter (mg/L) | From enrollment to the end of intervention at 4 months | Change in C-reactive protein (CRP) from baseline to the 4-month visit. The value is reported in milligram per liter (mg/L). |
| change in blood pressure in millimeters of mercury (mmHg) | From enrollment to the end of intervention at 4 months | Change in systolic and diastolic blood pressure from baseline to the 4-month visit. The values are reported in millimeters of mercury (mmHg). |
Countries
China
Contacts
CONTACTYuxia Wei, PhD
CONTACTAn Pan, PhD
PRINCIPAL_INVESTIGATORAn Pan
Huazhong University of Science and Technology
Outcome results
None listed