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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Pectin

    Dietary supplement

    15g of pectin with 10g of cocoa powder added as flavour were randomly allocated to eligible participants.

  • Cocoa Powder

    Other intervention

    10g of cocoa powder served as the control/ placebo to compare the effects observed with pectin.

  • Magnetic Resonance Imaging with Contrast

    Diagnostic test

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: PectinActive comparator 1 intervention
Group B: Cocoa PowderPlacebo comparator 1 intervention
Group C: Magnetic resonance imaging (MRI) ValidationOther 1 intervention

Trial outcomes

Primary outcomes

1

Quantification of blood markers contributing to systemic inflammation pathway (TNFα (pg/mL), IL-6 (pg/mL), IL-10 (pg/mL), IFNᵞ (pg/mL), C-Reactive Protein (pg/mL), Zonulin (Haptoglobulin)(pg/m), IL-1β(pg/mL)).

Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 6-weeks intervention period.

Time frame
6 weeks

Secondary outcomes

1

Change in BMI (kg/m²)

Changes in BMI pre and post the 6-weeks intervention period.

Time frame
6 weeks
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)

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) pre and post the 6-weeks intervention period.

Time frame
6 weeks
3

Assessment of changes in 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.

Changes in 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 pre and post the 6-weeks intervention period.

Time frame
6 weeks
4

Change in Liver Stiffness via Transient Elastography

CAP and liver stiffness (in kPa) measured using transient elastography.

Time frame
6 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nottingham

Lead sponsor

Nottingham University Hospitals NHS Trust

Collaborator

Source ClinicalTrials.gov
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