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

NCT07093346 | Recruiting

• 2 other identifiers: 24076351797
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

LM pectin; pectin; MASLD; NAFLD; Nonalcoholic Fatty Liver Disease; Systemic Inflammatory Response; Dietary Fiber; Dietary Fibre; Diet; gut microbiota; Metabolic Dysfunction-Associated Steatotic Liver Disease

Outcome Measures

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.

  6 weeks

Secondary Outcomes (11)

• Change in BMI (kg/m²)

  6 weeks

• 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)

  6 weeks

• 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.

  6 weeks

• Change in Liver Stiffness via Transient Elastography

  6 weeks

• Change in Liver Fat Fraction Assessed by Dixon MRI Sequence.

  6 weeks

Study Arms (3)

Pectin

ACTIVE COMPARATOR

15g/day of pectin with 10g/day of cocoa powder added as flavour will be provided to participants for 6 weeks.

Dietary Supplement: Pectin

Cocoa Powder

PLACEBO COMPARATOR

10g/day of cocoa powder will be provided to participants for 6 weeks.

Other: Cocoa Powder

Magnetic resonance imaging (MRI) Validation

OTHER

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.

Diagnostic Test: Magnetic Resonance Imaging with Contrast

Interventions

Pectin DIETARY_SUPPLEMENT

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

Pectin

Cocoa Powder OTHER

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

Cocoa Powder

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.

Also known as: MRI

Magnetic resonance imaging (MRI) Validation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Have chronic malnutrition condition.
• History of major surgery which potentially limits participation or completion of the study.
• History of previous intestinal surgery known to affect food intake or digestive function, including bariatric surgery.
• Use of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.
• Are taking the following medications: immunosuppressants, amiodarone and/or perhexiline.
• Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program or concomitant use of any weight loss medication or herbal weight loss products.
• History of side effects towards probiotics or prebiotics.
• History or current psychiatric illness.
• History or current neurological condition (e.g. epilepsy).
• Participants with other liver abnormalities.
• Evidence of monogenic metabolism diseases such as Lysosomal acid lipase deficiency (LALD), Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism.

Sponsors & Collaborators

• University of Nottingham: lead
• Nottingham University Hospitals NHS Trust: collaborator

Study Sites (3)

Sir Peter Mansfield Imaging Centre, University of Nottingham

Nottingham, NG7 2QX, United Kingdom

RECRUITING

Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

RECRUITING

University of Nottingham

Nottingham, NG7 2UH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Pectins; Chocolate; Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• 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

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

Central Study Contacts

Noor K Al-Tameemi, PhD student candidate

CONTACT

0044 01158231149; noorkifahabdulhussein.al-tameemi@nottingham.ac.uk

Guruprasad P Aithal, Professor

CONTACT

0044 01158231149; guru.aithal@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a parallel design, placebo-controlled, randomised dietary intervention study in which each participant will be randomly assigned to either pectin supplementation arm or control arm using online software (sealedenvelope.com).

Study Record Dates

• First Submitted: July 8, 2025
• First Posted: July 30, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-04

Locations

GB (3)