At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Pectin (supplement), Cocoa Powder (other), Magnetic Resonance Imaging with Contrast (diagnostic test)
- How long the study runs
- Study runs about 21 months (dates as stated)
- About the drug or intervention
- Pectin — supplement: 15g of pectin with 10g of cocoa powder added as flavour were randomly allocated to eligible participants. · Cocoa Powder — other: 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 45
- Started
- 2025-06-10
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for nonalcoholic fatty liver disease
- • NA - 45 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with nonalcoholic fatty liver disease
Where?
- • Nottingham - University of Nottingham
- • Nottingham - Sir Peter Mansfield Imaging Centre, University of Nottingham
- • Nottingham - Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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
More detail
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.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Inclusion criteria for the main study:
- ✓Participants willing and able to give agreement to take part 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...
- ✓For diabetic participants: controlled blood glucose levels Haemoglobin A1C (HbA1c) \<7.0% (\<53 mmol/mol) \[1\].
- ✓Able to undergo CAP-FibroScan™.
Who cannot take part
- ✗Exclusion criteria for the main study:
- ✗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,...
See the full criteria
Where Is This Study? (3 UK sites)
University of Nottingham
Nottingham NG7 2UH, United Kingdom
Sir Peter Mansfield Imaging Centre, University of Nottingham
Nottingham NG7 2QX, United Kingdom
Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust
Nottingham NG7 2UH, United Kingdom
How to Get in Touch
Noor K Al-Tameemi, PhD student candidate
Sponsor contactCONTACT
Guruprasad P Aithal, Professor
Sponsor contactCONTACT
