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

1 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

600

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • 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
      • Xiangyang, Hubei, China
        • Xiangyang No.1 People's hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
Voedingssupplement: inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
Placebo-vergelijker: maltodextrin
The intake dose is 10 grams per day for 4 months.
Voedingssupplement: Placebo Comparator: maltodextrin
The dose is 10 grams per day for 4 months.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
change in concentrations of blood lipid levels in millimole per liter (mmol/L).
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
change in frequency of gastrointestinal symptoms
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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 (%)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Huazhong University of Science and Technology

Onderzoekers

  • Hoofdonderzoeker: An Pan, Huazhong University of Science and Technology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 november 2026

Studie voltooiing (Geschat)

1 november 2026

Studieregistratiedata

Eerst ingediend

21 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

21 mei 2026

Eerst geplaatst (Werkelijk)

28 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Prebiotics in GLP-1 RA users

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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