Effects of Inulin on Cardiometabolic Risk Factors in Individuals Using Glucagon-like Peptide-1 Receptor Agonists (GLP-1 RA ) Medications for Weight Loss

NCT07611552 | Not Yet Recruiting

• 1 other identifier: Prebiotics in GLP-1 RA users
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Obesity & Overweight

Keywords

weight loss; cardiometabolic risk factors; prebiotics; lipids; glucagon-like peptide-1 receptor agonists (GLP-1 RA)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• 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

Study Arms (2)

inulin (prebiotics)

EXPERIMENTAL

The intervention dose is 10 grams per day. The intervention will last for 4 months.

Dietary Supplement: inulin (prebiotics)

maltodextrin

PLACEBO COMPARATOR

The intake dose is 10 grams per day for 4 months.

Dietary Supplement: Placebo Comparator: maltodextrin

Interventions

inulin (prebiotics) DIETARY_SUPPLEMENT

The intervention dose is 10 grams per day. The intervention will last for 4 months.

inulin (prebiotics)

Placebo Comparator: maltodextrin DIETARY_SUPPLEMENT

The dose is 10 grams per day for 4 months.

maltodextrin

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (5)

The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

Enshi, Hubei, China

Location

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, China

Location

Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

Xiangyang No.1 People's Hospital

Xiangyang, Hubei, China

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Interventions

Inulin; Prebiotics

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides; Dietary Fiber; Polysaccharides, Bacterial; Food; Diet, Food, and Nutrition; Physiological Phenomena; Dietary Supplements; Food and Beverages

Study Officials

• An Pan

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuxia Wei, PhD

CONTACT

86-18813185223; 2026020052@hust.edu.cn

An Pan, PhD

CONTACT

86-18186123783; panan@hust.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)