Not yet recruiting NCT07611552

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

No phase Interventional Obesity & Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: inulin (prebiotics), Placebo Comparator: maltodextrin.
Who it may be relevant to: Registry conditions: Obesity & Overweight. Basic parameters: 18 years — 64 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

Detailed description

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.

Interventions

Dietary supplement inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
Dietary supplement Placebo Comparator: maltodextrin
The dose is 10 grams per day for 4 months.

Primary outcome measures

change in concentrations of blood lipid levels in millimole per liter (mmol/L). [Time frame: From enrollment to the end of intervention at 4 months]

Secondary outcome measures (12)

change in frequency of gastrointestinal symptoms [Time frame: From enrollment to the end of intervention at 4 months]
change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol) [Time frame: From enrollment to the end of intervention at 4 months]
change in level of insulin resistance [Time frame: From enrollment to the end of intervention at 4 months]
change in body weight in kilograms (kg) [Time frame: From enrollment to the end of intervention at 4 months]
change in body fat percentage (%) [Time frame: From enrollment to the end of intervention at 4 months]
change in waist circumference in centimeters (cm) [Time frame: From enrollment to the end of intervention at 4 months]
change in level of gut microbiota abundance [Time frame: From enrollment to the end of intervention at 4 months]
change in level of gut microbiota diversity [Time frame: 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) [Time frame: From enrollment to the end of intervention at 4 months]
change in concentrations of liver function markers in units per liter (U/L) [Time frame: From enrollment to the end of intervention at 4 months]
change in level of C-reactive protein (CRP) in milligram per liter (mg/L) [Time frame: From enrollment to the end of intervention at 4 months]
change in blood pressure in millimeters of mercury (mmHg) [Time frame: From enrollment to the end of intervention at 4 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Prevention

Study locations

China · 5 centers

The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture — Enshi
Sinopharm Dongfeng General Hospital — Shiyan
Huazhong University of Science and Technology — Wuhan
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Xiangyang No.1 People's Hospital — Xiangyang

Identifiers

NCT: NCT07611552 · Prebiotics in GLP-1 RA users

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗