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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
600
The intervention dose is 10 grams per day. The intervention will last for 4 months.
The dose is 10 grams per day for 4 months.
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
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
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.
Time frame: From enrollment to the end of intervention at 4 months
change in frequency of gastrointestinal symptoms
change in frequency of gastrointestinal symptoms such as diarrhea and constipation baseline to 4-month visit
Time frame: From enrollment to the end of intervention at 4 months
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.
Time frame: From enrollment to the end of intervention at 4 months
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).
Time frame: From enrollment to the end of intervention at 4 months
change in body weight in kilograms (kg)
Change in body weight (kg) from baseline to 4-month visit
Time frame: From enrollment to the end of intervention at 4 months
change in body fat percentage (%)
change in body fat percentage from baseline to 4-month visit. The values will be reported in percentage (%).
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Xiangyang No.1 People's Hospital
Xiangyang, Hubei, China
Time frame: From enrollment to the end of intervention at 4 months
change in waist circumference in centimeters (cm)
Change in waist Circumference (cm) from baseline to the 4-month visit.
Time frame: From enrollment to the end of intervention at 4 months
change in level of gut microbiota abundance
Change in gut microbiota abundance from baseline to 4-month visit
Time frame: From enrollment to the end of intervention at 4 months
change in level of gut microbiota diversity
Change in gut microbiota alpha and beta diversity from baseline to 4-month visit.
Time frame: From enrollment to the end of intervention at 4 months
change in estimated glomerular filtration rate (eGFR) in milliliter per minute per 1.73 square meters (mL/min/1.73 m²)
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).
Time frame: From enrollment to the end of intervention at 4 months
change in concentrations of liver function markers in units per liter (U/L)
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).
Time frame: From enrollment to the end of intervention at 4 months
change in level of C-reactive protein (CRP) in milligram per liter (mg/L)
Change in C-reactive protein (CRP) from baseline to the 4-month visit. The value is reported in milligram per liter (mg/L).
Time frame: From enrollment to the end of intervention at 4 months
change in blood pressure in millimeters of mercury (mmHg)
Change in systolic and diastolic blood pressure from baseline to the 4-month visit. The values are reported in millimeters of mercury (mmHg).
Time frame: From enrollment to the end of intervention at 4 months