Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07093346

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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