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Obesity & OverweightNCT07611552

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

A study testing inulin (prebiotics) in people with Obesity & Overweight, run by Huazhong University of Science and Technology at 5 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Obesity & Overweight
What is being tested?
inulin (prebiotics)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
5 sitesChina
Study dates
Jun 2026to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yuxia Wei, PhD contact

86-18813185223

2026020052@hust.edu.cn

An Pan, PhD contact

86-18186123783

panan@hust.edu.cn

5 sites in 1 country

China5 sites

  • The Central Hospital of Enshi Tujia and Miao Autonomous Prefecture

    Enshi, Hubei

  • Sinopharm Dongfeng General Hospital

    Shiyan, Hubei

  • Huazhong University of Science and Technology

    Wuhan, Hubei

    Yuxia Wei, PhD, 86-18813185223, 2026020052@hust.edu.cn

    An Pan, PhD, panan@hust.edu.cn

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

    Wuhan, Hubei

  • Xiangyang No.1 People's Hospital

    Xiangyang, Hubei

Other trials in China

About this study

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

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.

Read the 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.

Being tested
inulin (prebiotics), Placebo Comparator: maltodextrin
Keywords
weight loss, cardiometabolic risk factors, prebiotics, lipids, glucagon-like peptide-1 receptor agonists (GLP-1 RA)
Medical subject headings
Obesity, Overweight, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • inulin (prebiotics)Dietary supplement

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

  • Placebo Comparator: maltodextrinDietary supplement

    The dose is 10 grams per day for 4 months.

Study groups in NCT07611552
Study groupRoleWhat they receive
inulin (prebiotics)ExperimentalThe intervention dose is 10 grams per day. The intervention will last for 4 months.
Receives: Dietary Supplement: inulin (prebiotics)
maltodextrinPlacebo comparatorThe intake dose is 10 grams per day for 4 months.
Receives: Dietary Supplement: Placebo Comparator: maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From enrollment to the end of intervention at 4 months

Secondary outcomes (12)

  1. change in frequency of gastrointestinal symptoms

    change in frequency of gastrointestinal symptoms such as diarrhea and constipation baseline to 4-month visit

    Measured: From enrollment to the end of intervention at 4 months

  2. change in concentration of glycosylated Hemoglobin A1c (HbA1c) in millimoles per mole (mmol/mol)

    Description: change in concentration of glycosylated Hemoglobin A1c (HbA1c) from baseline to 4-month visit. The values will be reported in mmol/mol.

    Measured: From enrollment to the end of intervention at 4 months

  3. change in level of insulin resistance

    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).

    Measured: From enrollment to the end of intervention at 4 months

  4. change in body weight in kilograms (kg)

    Change in body weight (kg) from baseline to 4-month visit

    Measured: From enrollment to the end of intervention at 4 months

  5. change in body fat percentage (%)

    change in body fat percentage from baseline to 4-month visit. The values will be reported in percentage (%).

    Measured: From enrollment to the end of intervention at 4 months

  6. change in waist circumference in centimeters (cm)

    Change in waist Circumference (cm) from baseline to the 4-month visit.

    Measured: From enrollment to the end of intervention at 4 months

  7. change in level of gut microbiota abundance

    Change in gut microbiota abundance from baseline to 4-month visit

    Measured: From enrollment to the end of intervention at 4 months

  8. change in level of gut microbiota diversity

    Change in gut microbiota alpha and beta diversity from baseline to 4-month visit.

    Measured: From enrollment to the end of intervention at 4 months

  9. change in estimated glomerular filtration rate (eGFR) in milliliter per minute per 1.73 square meters (mL/min/1.73 m²)

    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).

    Measured: From enrollment to the end of intervention at 4 months

  10. change in concentrations of liver function markers in units per liter (U/L)

    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).

    Measured: From enrollment to the end of intervention at 4 months

  11. change in level of C-reactive protein (CRP) in milligram per liter (mg/L)

    Change in C-reactive protein (CRP) from baseline to the 4-month visit. The value is reported in milligram per liter (mg/L).

    Measured: From enrollment to the end of intervention at 4 months

  12. change in blood pressure in millimeters of mercury (mmHg)

    Change in systolic and diastolic blood pressure from baseline to the 4-month visit. The values are reported in millimeters of mercury (mmHg).

    Measured: From enrollment to the end of intervention at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2026
  2. Study startJun 2026 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07611552
Sponsor's protocol ID
Prebiotics in GLP-1 RA users
Status last verified
Jun 2026
First submitted
21 May 2026
Last updated
3 Jun 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: To protect the privacy of participants, the investigators decide not to share individual data.

Questions about this trial

What is this clinical trial studying?

A study testing inulin (prebiotics) in people with Obesity & Overweight, run by Huazhong University of Science and Technology at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuxia Wei, PhD (86-18813185223, 2026020052@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07611552.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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