Cette page a été traduite automatiquement et l'exactitude de la traduction n'est pas garantie. Veuillez vous référer au version anglaise pour un texte source.

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

1 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

600

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

Inclusion criteria:

  • Be overweight or obese (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.
  • 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
Complément alimentaire: inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
Comparateur placebo: maltodextrin
The intake dose is 10 grams per day for 4 months.
Complément alimentaire: Placebo Comparator: maltodextrin
The dose is 10 grams per day for 4 months.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
change in concentrations of blood lipid levels in millimole per liter (mmol/L).
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
change in frequency of gastrointestinal symptoms
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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 (%)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Huazhong University of Science and Technology

Les enquêteurs

  • Chercheur principal: An Pan, Huazhong University of Science and Technology

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 juin 2026

Achèvement primaire (Estimé)

1 novembre 2026

Achèvement de l'étude (Estimé)

1 novembre 2026

Dates d'inscription aux études

Première soumission

21 mai 2026

Première soumission répondant aux critères de contrôle qualité

21 mai 2026

Première publication (Réel)

28 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

3 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • Prebiotics in GLP-1 RA users

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

To protect the privacy of participants, the investigators decide not to share individual data.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

S'abonner