Actively Recruiting
The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Led by University of Nottingham · Updated on 2025-07-30
45
Participants Needed
3
Research Sites
94 weeks
Total Duration
On this page
Sponsors
U
University of Nottingham
Lead Sponsor
N
Nottingham University Hospitals NHS Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of MASLD (previously called NAFLD) with liver fat over 5% by histology or imaging
- Willing and able to give informed consent
- Aged 18 years or older with BMI between 18.5 and 39.9 kg/m2 and stable weight (less than or equal to 3 kg change) in past 3 months
- For diabetics, HbA1c less than 7.0% (less than 53 mmol/mol)
- Able to undergo CAP-FibroScan13
- For healthy MRI participants: aged 18 or older with CAP less than 250 kPa and liver stiffness less than 8 kPa by FibroScan13 within 6 months
You will not qualify if you...
- Allergy to soya, milk, chocolate, or pectin
- On a vegan diet
- Eating disorders, gastrointestinal conditions like coeliac disease, IBS, IBD, or gastroparesis
- Chronic malnutrition
- History of major surgery limiting participation
- Previous intestinal or bariatric surgery affecting digestion
- Use of antibiotics, antifungals, probiotics, or prebiotics within 90 days before study
- Taking immunosuppressants, amiodarone, or perhexiline
- Following or planning a specialized weight loss diet or medication
- History of side effects to probiotics or prebiotics
- Current or past psychiatric illness
- Current or past neurological conditions such as epilepsy
- Other liver abnormalities
- Monogenic metabolic diseases like LALD, Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism
- Weight change over 3 kg in past 3 months
- Uncontrolled diabetes, active cancer, or chronic infections
- Symptoms of active infection
- Excessive alcohol intake (more than 21 units/week for men, 14 units/week for women)
- Pregnant, breastfeeding, or planning pregnancy
- Participation in another clinical trial within last 3 months
- Contraindications to MRI including pacemakers, metal implants, or foreign bodies
- Difficulty breathing, inability to lie flat, or severe anxiety/claustrophobia preventing MRI scans
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Sir Peter Mansfield Imaging Centre, University of Nottingham
Nottingham, United Kingdom, NG7 2QX
Actively Recruiting
2
Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
3
University of Nottingham
Nottingham, United Kingdom, NG7 2UH
Actively Recruiting
Research Team
N
Noor K Al-Tameemi, PhD student candidate
CONTACT
G
Guruprasad P Aithal, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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