NCT07093346

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: University of Nottingham · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Primary Objective: This research aims to study the effects of daily ingestion of LM pectin on inflammation pathways by measuring the blood inflammatory markers associated with physiological processes (TNFα, IL-6, IL-10, IFNᵞ, C - reactive protein, Zonulin (Haptoglobulin), IL-1β). Secondary Objectives: 1. Assessment of changes in anthropometric measures. 2. Assessment of changes in general metabolic indicators, such as fasting blood glucose and other blood-based markers relevant to MASLD (e.g., CK18-M30, CK18-M65, PROC3, Enhanced Liver Fibrosis (ELF), NIS2+™, YKL-40, microRNA miR-34a-5p, liver-associated enzymes such as Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), gamma-glutamyl transferase (GGT), Alkaline Phosphatase (ALP)), bilirubin levels, lipid profiles, and platelet counts. 3. Exploration of changes in gut microbiome composition. 4. Exploration of modifications in non-invasive physiological assessments linked to liver characteristics, such as fat content and stiffness through controlled attenuation parameter (CAP) and transient elastography. 5. Observation of alteration in fat in liver and other surrounding abdominal organs through Dixon MRI sequence in patients who will agree to have 2 MRI scans. 6. Validation of MRI measures (T2\*) as a tool to measure gut permeability among MASLD patients and investigation of changes in gut permeability in participants undergoing two MRI scans. 7. Investigation the presence of gene variants such as MUC2, encoding Mucin protein, that are associated with gut permeability.

Conditions

• Nonalcoholic 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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pectin	15g of pectin with 10g of cocoa powder added as flavour were randomly allocated to eligible participants.
OTHER	Cocoa Powder	10g of cocoa powder served as the control/ placebo to compare the effects observed with pectin.
DIAGNOSTIC_TEST	Magnetic Resonance Imaging with Contrast	To validate MRI scans as a tool to assess intestinal wall thickness to indicate gut permeability on MASLD patients, the investigators will scan 15 healthy volunteers twice, at baseline and after 6 weeks, and then compare their results with MASLD participant results at baseline and after 6 weeks.

Timeline

• Start date: 2025-06-10
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

3 sites across 1 country: United Kingdom