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
Location: See all (3) locations...
Intervention Type: Dietary supplement, Diagnostic test, Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
United Kingdom
Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Sir Peter Mansfield Imaging Centre, University of Nottingham
RECRUITING
Nottingham
University of Nottingham
RECRUITING
Nottingham
Contact Information
Primary
Noor K Al-Tameemi, PhD student candidate
noorkifahabdulhussein.al-tameemi@nottingham.ac.uk
0044 01158231149
Backup
Guruprasad P Aithal, Professor
guru.aithal@nottingham.ac.uk
0044 01158231149
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 45
Treatments
Active_comparator: Pectin
15g/day of pectin with 10g/day of cocoa powder added as flavour will be provided to participants for 6 weeks.
Placebo_comparator: Cocoa Powder
10g/day of cocoa powder will be provided to participants for 6 weeks.
Other: Magnetic resonance imaging (MRI) Validation
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.
Related Therapeutic Areas
Sponsors
Collaborators: Nottingham University Hospitals NHS Trust
Leads: University of Nottingham

This content was sourced from clinicaltrials.gov