Low‑methoxy pectin for inflammation, gut microbiome, and metabolic health in MASLD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with recently diagnosed MASLD will be assigned to take either 15 g of low‑methoxy (LM) pectin plus 10 g cocoa powder daily or a placebo plus 10 g cocoa powder for six weeks. The study measures blood inflammatory markers (for example TNFα, IL‑6, IL‑10, IFNγ, CRP, zonulin, IL‑1β), a range of metabolic and liver biomarkers, anthropometrics, and gut microbiome composition. Noninvasive liver tests (CAP by FibroScan and transient elastography) are used for all participants, and a subset may have two MRI scans to track organ fat and explore MRI-based gut permeability measures. The trial compares changes between the pectin and placebo groups to see if LM pectin produces measurable biological or clinical changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Inclusion criteria for the main study:

* 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™.

Inclusion criteria for healthy participants who will have MRI scans:

* 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.

Exclusion Criteria:

Exclusion criteria for the main study:

* Have allergy toward soya, milk or chocolate.
* Have allergy toward pectin.
* Participants on vegan diet.
* 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 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.
* History of side effects towards probiotics or prebiotics.
* History or current psychiatric illness.
* History or current neurological condition (e.g. epilepsy).
* Participants with other liver abnormalities.
* Evidence of monogenic metabolism diseases such as Lysosomal acid lipase deficiency (LALD), Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism.
* Have had a weight change exceeding 3 kg within 3 months.
* Uncontrolled diabetes, active malignancy, or chronic infections.
* Having symptoms of active infection.
* 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.

Exclusion criteria for healthy volunteers MRI scans and patients optional MRI scans:

* 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.

Where it's running

• University of Nottingham
  Nottingham, United Kingdom, United Kingdom Recruiting
• Sir Peter Mansfield Imaging Centre, University of Nottingham
  Nottingham, United Kingdom Recruiting
• Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust
  Nottingham, United Kingdom Recruiting

Study contacts

• Principal investigator: Guruprasad P Aithal, Professor — Nottingham Digestive Diseases Centre & NIHR Nottingham Biomedical Research Centre, Nottingham, University Hospitals NHS Trust and the University of Nottingham, Queens Medical Centre Nottingham, NG7 2UH
• Study coordinator: Noor K Al-Tameemi, PhD student candidate
• Email: noorkifahabdulhussein.al-tameemi@nottingham.ac.uk
• Phone: 0044 01158231149

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Ultraportable Hepatoscope ultrasound for measuring liver fat in MASLD/MASH

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.