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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| inulin (prebiotics) | Experimental | The intervention dose is 10 grams per day. The intervention will last for 4 months. |
|
| maltodextrin | Placebo Comparator | The intake dose is 10 grams per day for 4 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inulin (prebiotics) | Dietary Supplement | The intervention dose is 10 grams per day. The intervention will last for 4 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to the end of intervention at 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| change in frequency of gastrointestinal symptoms | change in frequency of gastrointestinal symptoms such as diarrhea and constipation baseline to 4-month visit | From enrollment to the end of intervention at 4 months |
| change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol) |
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Inclusion criteria:
Be overweight or obese (meeting any of the following criteria):
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuxia Wei, PhD | Contact | 86-18813185223 | 2026020052@hust.edu.cn | |
| An Pan, PhD | Contact | 86-18186123783 | panan@hust.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| An Pan | Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture | Enshi | Hubei | China | |||
| Sinopharm Dongfeng General Hospital |
To protect the privacy of participants, the investigators decide not to share individual data.
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| Placebo Comparator: maltodextrin | Dietary Supplement | The dose is 10 grams per day for 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. |
| 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). | 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 | 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 (%). | 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. | 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 | 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. | 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). | 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). | 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). | 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). | From enrollment to the end of intervention at 4 months |
| 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 |
| Xiangyang No.1 People's Hospital | Xiangyang | Hubei | China |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
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| ID | Term |
|---|---|
| D007444 | Inulin |
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D013213 | Starch |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005630 | Fructans |
| D011134 | Polysaccharides |
| D004043 | Dietary Fiber |
| D011135 | Polysaccharides, Bacterial |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |
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