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

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

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

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.

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• University of Nottingham

  lead OTHER

Principal Investigators

• Noor K Al-Tameemi, PhD student candidate · 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

• 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

• Jane Grove, Associate 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 Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-10

Primary Completion

2027-03-31

Completion

2027-03-31

Countries

• United Kingdom

Study Locations