The Effect of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA) Medications for Weight Loss: a Randomized Double-blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 5
- 主要终点
- change in concentrations of blood lipid levels in millimole per liter (mmol/L).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be overweight or obese (meeting any of the following criteria):
- •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.
- •Consent to participate and sign the informed consent form.
排除标准
- •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.
研究组 & 干预措施
inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
干预措施: inulin (prebiotics) (Dietary Supplement)
maltodextrin
The intake dose is 10 grams per day for 4 months.
干预措施: Placebo Comparator: maltodextrin (Dietary Supplement)
结局指标
主要结局
change in concentrations of blood lipid levels in millimole per liter (mmol/L).
时间窗: 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.
次要结局
- change in frequency of gastrointestinal symptoms(From enrollment to the end of intervention at 4 months)
- change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol)(From enrollment to the end of intervention at 4 months)
- change in level of insulin resistance(From enrollment to the end of intervention at 4 months)
- change in body weight in kilograms (kg)(From enrollment to the end of intervention at 4 months)
- change in body fat percentage (%)(From enrollment to the end of intervention at 4 months)
- change in waist circumference in centimeters (cm)(From enrollment to the end of intervention at 4 months)
- change in level of gut microbiota abundance(From enrollment to the end of intervention at 4 months)
- change in level of gut microbiota diversity(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)(From enrollment to the end of intervention at 4 months)
- 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 level of C-reactive protein (CRP) 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)(From enrollment to the end of intervention at 4 months)
研究者
An Pan
Professor
Huazhong University of Science and Technology