Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA ) Medications for Weight Loss
2026年6月1日 更新者：An Pan、Huazhong University of Science and Technology
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
600
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yuxia Wei, PhD
- 电话号码：86-18813185223
- 邮箱：2026020052@hust.edu.cn
研究联系人备份
- 姓名：An Pan, PhD
- 电话号码：86-18186123783
- 邮箱：panan@hust.edu.cn
学习地点
-
-
Hubei
-
Enshi、Hubei、中国
- The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
-
Shiyan、Hubei、中国
- Sinopharm Dongfeng General Hospital
-
Wuhan、Hubei、中国
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
-
Wuhan、Hubei、中国
- Huazhong University of Science and Technology
-
接触：
- Yuxia Wei, PhD
- 电话号码：86-18813185223
- 邮箱：2026020052@hust.edu.cn
-
接触：
- An Pan, PhD
- 邮箱：panan@hust.edu.cn
-
Xiangyang、Hubei、中国
- Xiangyang No.1 People's hospital
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion criteria:
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.
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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：inulin (prebiotics)
The intervention dose is 10 grams per day.
The intervention will last for 4 months.
|
The intervention dose is 10 grams per day.
The intervention will last for 4 months.
|
|
安慰剂比较：maltodextrin
The intake dose is 10 grams per day for 4 months.
|
The dose is 10 grams per day for 4 months.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in concentrations of blood lipid levels in millimole per liter (mmol/L).
大体时间：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.
|
From enrollment to the end of intervention at 4 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
change in frequency of gastrointestinal symptoms
大体时间：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
|
From enrollment to the end of intervention at 4 months
|
|
change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol)
大体时间：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.
|
From enrollment to the end of intervention at 4 months
|
|
change in level of insulin resistance
大体时间：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).
|
From enrollment to the end of intervention at 4 months
|
|
change in body weight in kilograms (kg)
大体时间：From enrollment to the end of intervention at 4 months
|
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 (%)
大体时间：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 (%).
|
From enrollment to the end of intervention at 4 months
|
|
change in waist circumference in centimeters (cm)
大体时间：From enrollment to the end of intervention at 4 months
|
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
大体时间：From enrollment to the end of intervention at 4 months
|
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
大体时间：From enrollment to the end of intervention at 4 months
|
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)
大体时间：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).
|
From enrollment to the end of intervention at 4 months
|
|
change in concentrations of liver function markers in units per liter (U/L)
大体时间：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).
|
From enrollment to the end of intervention at 4 months
|
|
change in level of C-reactive protein (CRP) in milligram per liter (mg/L)
大体时间：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).
|
From enrollment to the end of intervention at 4 months
|
|
change in blood pressure in millimeters of mercury (mmHg)
大体时间：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).
|
From enrollment to the end of intervention at 4 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：An Pan、Huazhong University of Science and Technology
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年6月1日
初级完成 (估计的)
2026年11月1日
研究完成 (估计的)
2026年11月1日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年5月21日
首次发布 (实际的)
2026年5月28日
研究记录更新
最后更新发布 (实际的)
2026年6月3日
上次提交的符合 QC 标准的更新
2026年6月1日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- Prebiotics in GLP-1 RA users
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
To protect the privacy of participants, the investigators decide not to share individual data.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.