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

ConditionsNonalcoholic Fatty Liver Disease Nonalcoholic Fatty Liver Disease (NAFLD)MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease MASLD NAFLD Metabolic Dysfunction-Associated Steatotic Liver Disease NAFLD (Nonalcoholic Fatty Liver Disease)NAFLD (Non-alcoholic Fatty Liver Disease)NAFLD - Non-Alcoholic Fatty Liver Disease NAFLD - Nonalcoholic Fatty Liver Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Nottingham

About this trial

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

Eligibility criteria

Qualifiers

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].

Disqualifiers

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.

Trial design

Treatments tested in this trial

Pectin
Cocoa Powder
Magnetic Resonance Imaging with Contrast

Treatment groups

45 Participants

are divided into 3 treatment groups

Sponsors and collaborators

University of Nottingham

Lead sponsor

Nottingham University Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov