Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using GLP-1 RA Medications for Weight Loss

The Effect of Inulin on Cardiometabolic Risk Factors in Individuals Using 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, 10g/day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving GLP-1 RA medications for weight loss.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity & Overweight
• Intervention / Treatment: Dietary supplement: inulin (prebiotics); Dietary supplement: Placebo Comparator: maltodextrin

Detailed Description

The goal of this double-blind randomized placebo-controlled supplement study is to investigate if the supplement of inulin (prebiotics, 10g/day) has beneficial effects on cardiometabolic risk factors in overweight or obese individuals receiving 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
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuxia Wei, PhD; Phone Number: 86-18813185223; Email: 2026020052@hust.edu.cn
• Study Contact Backup: Name: An Pan, PhD; Phone Number: 86-18186123783; Email: panan@hust.edu.cn

Study Locations

• China
  • Hubei
    • Enshi, Hubei, China
      • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture
    • Shiyan, Hubei, China
      • Sinopharm Dongfeng General Hospital
    • Wuhan, Hubei, China
      • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
    • Wuhan, Hubei, China
      • Huazhong University of Science and Technology
      • Contact: Yuxia Wei, PhD; Phone Number: 86-18813185223; Email: 2026020052@hust.edu.cn
      • Contact: An Pan, PhD; Email: panan@hust.edu.cn
    • Xiangyang, Hubei, China
      • Xiangyang No.1 People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Participants must meet the following four inclusion criteria:

1. Overweight or obese patients (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.

2. Participants 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.

3. Age 18-64 years.

4. Consent to participate and sign the informed consent form.

-

Individuals meeting any of the following criteria will be ineligible:

1. Currently using non-GLP-1 RA medications for weight-loss, or have undergone or plan to undergo within the next 4 months, weight-loss procedures such as bariatric surgery, acupuncture thread embedding and liposuction; 2. Long-term user of prebiotics or probiotics (excluding fermented dairy products such as yogurt); 3. Allergic or intolerance to inulin-type substances; 4. Have participated in in other clinical trials within the past 3 months or are currently participating in other clinical trials; 5. Plan to be pregnant within the next year, are currently pregnant, or are breastfeeding; 6. Deemed unsuitable for participation by the investigator's judgment.

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: inulin (prebiotics); The intervention dose is 10g/day. The intervention will last for 4 months.	Dietary supplement: inulin (prebiotics); The intervention dose is 10g/day. The intervention will last for 4 months.
Placebo Comparator: maltodextrin; The intake dose is 10g/day for 4 months.	Dietary supplement: Placebo Comparator: maltodextrin; The dose is 10g/day for 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood lipid levels	change in total cholesterol and triglycerides levels from baseline to 4-month visit	From enrollment to the end of intervention at 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
glycemic control	Description: change in concentration of glycosylated Hemoglobin A1c (HbA1c) from baseline to 4-month visit	From enrollment to the end of intervention at 4 months
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 and fasting insulin. Adipo-IR will be estimated using fasting insulin and fasting free fatty acids.	From enrollment to the end of intervention at 4 months
body weight	Change in body weight (kg) from baseline to 4-month visit	From enrollment to the end of intervention at 4 months
body fat percentage	change in body fat percentage (%) from baseline to 4-month visit.	From enrollment to the end of intervention at 4 months
waist circumference	Change in Waist Circumference (cm) from baseline to the 4-month visit.	From enrollment to the end of intervention at 4 months
gut microbiota abundance	Change in gut microbiota abundance from baseline to 4-month visit	From enrollment to the end of intervention at 4 months
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
eGFR	Change in estimated glomerular filtration rate (eGFR) from baseline to the 4-month visit. The 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
Liver function markers	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
C-reactive protein	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
blood pressure	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

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology
• Investigators: Principal Investigator: An Pan, Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 21, 2026
• First Posted (Actual): May 28, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: weight loss; lipids; prebiotics; GLP-1 RA; cardiometabolic risk factors
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Weight Loss; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Carbohydrates; Carbohydrates; Polymers; Macromolecular Substances; Polysaccharides; Starch; Glucans; Biopolymers; Fructans; Dietary Fiber; Polysaccharides, Bacterial; Inulin; Prebiotics
• Other Study ID Numbers: Prebiotics in GLP-1 RA users

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are unable to share the individual level data to pro

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No