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NCT07093346Recruiting

The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Randomised, Placebo-Controlled, Dietary Intervention Study

Source: ClinicalTrials.gov · Last updated 29 Jul 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn if daily supplementation with Low-methoxy (LM) pectin (polysaccharides extracted from citrus peels), which are commonly found in the UK diet (not pharmacological agents), can reduce systemic inflammation and improve gut microbiota composition in adults recently diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The main question it aims to answer is: -How does dietary Low-methoxy (LM) pectin supplementation affect systematic inflammation pathways such as those mediated by gut microbiota composition and what are the impacts on general metabolic indicators in individuals with MASLD? Researchers will compare a group taking 15g of LM-pectin with 10g of cocoa powder to a placebo group receiving 10g of placebo with 10g of cocoa powder to see if LM-pectin has measurable effects on inflammation and gut microbiota. Participants will: * Take a daily supplement for 6 weeks: either 15g of LM-pectin with 10g of cocoa powder (intervention), or 10g of placebo with 10g of cocoa powder (control) * Provide stool and fasting blood samples before and after the intervention * Undergo anthropometric measurements (weight, height, waist/hip ratio, and blood pressure) * Complete a case report form (CRF) including demographics and health/medical history * Undergo a FibroScan™ to assess liver health * (Optional) Participate in MRI scans to evaluate gut permeability

Status (registry)
Recruiting
Study type
Interventional
Enrollment
45 (estimated)
First submitted
8 Jul 2025
Start date
10 Jun 2025
Primary completion date
31 Mar 2027
Lead sponsor
University of Nottingham
NCT number
NCT07093346

What you commit to

  • Study type: Interventional
  • Planned participants: 45
  • From 10 Jun 2025 to the primary completion date, 31 Mar 2027
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of previous intestinal surgery known to affect food intake or digestive function, including bariatric surgery.
  • Use of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.
  • Are taking the following medications: immunosuppressants, amiodarone and/or perhexiline.
  • Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program or concomitant use of any weight loss medication or herbal weight loss products.

Other illness

  • Have allergy toward soya, milk or chocolate.
  • Have allergy toward pectin.
  • Have eating disorders or difficulties or gastrointestinal conditions e.g. malabsorptive conditions such as coeliac, Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) or gastroparesis.
  • Have chronic malnutrition condition.
  • History of major surgery which potentially limits participation or completion of the study.
  • History of side effects towards probiotics or prebiotics.
  • History or current psychiatric illness.
  • History or current neurological condition (e.g. epilepsy).
  • Evidence of monogenic metabolism diseases such as Lysosomal acid lipase deficiency (LALD), Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism.
  • Uncontrolled diabetes, active malignancy, or chronic infections.
  • Having symptoms of active infection.
  • Contraindications for MRI scanning: having pacemakers, defibrillators, neurostimulators, prohibited medical implants, and foreign bodies (e.g. bullets, shrapnel, metal slivers), history of metallic foreign body in eye(s) and penetrating eye injury that could present a risk during an MRI scan.
  • Difficulty breathing or inability to lie flat, as well as conditions that could worsen under stress (such as anxiety or panic disorders, claustrophobia, uncontrolled hypertension, or seizure disorders) severe enough to prevent undergoing an MRI.

Other

  • Participants on vegan diet.
  • Participants with other liver abnormalities.
  • Have had a weight change exceeding 3 kg within 3 months.
  • Excessive alcohol intake defined as self-reported intakes greater than 21 units per week in men, and 14 units per week in women.
  • Participants who are pregnant, breast feeding or actively planning pregnancy will be excluded from the study.
  • Participation in any other trial in the last 3 months.

Who the study is looking for

  • Patients with clinical diagnosis of MASLD (formerly termed non-alcoholic fatty liver disease (NAFLD)), having assessment suggesting that liver fat \> 5% (e.g. histological evidence or/ and Transient Elastography using Controlled Attenuation Parameter (CAP)- FibroScan™ in the past month and/or liver imaging (such as ultrasound, computerized tomography (CT) or magnetic resonance imaging (MRI)).
  • Participants willing and able to give informed consent for participation in the study.
  • Participants aged ≥18 years who have a body mass index (BMI) between 18.5 and 39.9 kg/m2 and stable weight (weight gain or loss ≤ 3kg) for the past 3 months.
  • For diabetic participants: controlled blood glucose levels Haemoglobin A1C (HbA1c) \<7.0% (\<53 mmol/mol) \[1\].
  • Able to undergo CAP-FibroScan™.
  • Participants willing and able to give informed consent for participation in the study.
  • Participants aged ≥18 years.
  • participants with CAP\<250 kpa\<8kP by a FibroScan™ within the past 6 months.

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sir Peter Mansfield Imaging Centre, University of Nottingham
Coordinator of this site? Confirm its status
NottinghamUnited KingdomRecruiting
University of Nottingham
Coordinator of this site? Confirm its status
NottinghamUnited KingdomRecruiting
Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust
Coordinator of this site? Confirm its status
NottinghamUnited KingdomRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.