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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 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

600

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Fyrdubbla

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
Kosttillskott: inulin (prebiotics)
The intervention dose is 10 grams per day. The intervention will last for 4 months.
Placebo-jämförare: maltodextrin
The intake dose is 10 grams per day for 4 months.
Kosttillskott: Placebo Comparator: maltodextrin
The dose is 10 grams per day for 4 months.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
change in concentrations of blood lipid levels in millimole per liter (mmol/L).
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
change in frequency of gastrointestinal symptoms
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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 (%)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Huazhong University of Science and Technology

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 juni 2026

Primärt slutförande (Beräknad)

1 november 2026

Avslutad studie (Beräknad)

1 november 2026

Studieregistreringsdatum

Först inskickad

21 maj 2026

Först inskickad som uppfyllde QC-kriterierna

21 maj 2026

Första postat (Faktisk)

28 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Prebiotics in GLP-1 RA users

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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