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): A Randomised, Placebo-Controlled, Dietary Intervention Study
Led by University of Nottingham · Updated on 2025-07-30
45
Participants Needed
3
Research Sites
N/A
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
Researchers are evaluating the effects of daily supplementation with Low-methoxy (LM) pectin, a dietary polysaccharide extracted from citrus peels commonly found in the UK diet, in adults recently diagnosed with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). The study aims to determine how LM pectin impacts systemic inflammation pathways, gut microbiota composition, and general metabolic indicators in individuals with MASLD. Participants will be randomly assigned to receive either 15g of LM pectin with 10g of cocoa powder or a placebo of 10g of placebo with 10g of cocoa powder daily for 6 weeks. Some healthy volunteers will also undergo MRI scans to validate these scans as a tool to assess gut permeability. The intervention period includes collection of stool and fasting blood samples, along with liver health assessments using FibroScan12 and optional MRI scans. During the 6-week study, participants will provide blood and stool samples, undergo physical measurements like weight, height, waist/hip ratio, and blood pressure, and complete health questionnaires. Researchers will measure blood markers related to inflammation and metabolic health, assess liver fat and stiffness, and analyze changes in gut microbiome and gut permeability. Safety and study outcomes will be closely monitored until the study completion in March 2027.
CONDITIONS
Brief 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...
- Patients clinically diagnosed with MASLD with liver fat greater than 5% confirmed by recent assessment such as FibroScan12 or imaging
- Participants willing and able to give informed consent
- Adults aged 18 years or older with body mass index (BMI) between 18.5 and 39.9 kg/m2 and stable weight (weight change within 3 kg) for the past 3 months
- For diabetic participants: controlled blood glucose with HbA1c less than 7.0% (53 mmol/mol)
- Able to undergo CAP-FibroScan12
- Healthy participants aged 18 years or older with CAP less than 250 kPa (for MRI scans)
You will not qualify if you...
- Allergy to soya, milk, chocolate, or pectin
- Following a vegan diet
- Having eating disorders or gastrointestinal conditions such as coeliac disease, IBS, IBD, or gastroparesis
- Chronic malnutrition
- History of major surgery limiting participation or completion
- Previous intestinal surgery affecting digestion, including bariatric surgery
- Use of antibiotics, antifungal medications, probiotics, or prebiotics within 90 days before study start
- Taking immunosuppressants, amiodarone, or perhexiline
- Following or planning to start specialized weight loss diets or medications
- History of side effects to probiotics or prebiotics
- History or current psychiatric illness
- History or current neurological conditions such as epilepsy
- Other liver abnormalities
- Evidence of monogenic metabolic diseases such as LALD, Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism
- Weight change exceeding 3 kg within 3 months
- Uncontrolled diabetes, active malignancy, or chronic infections
- Symptoms of active infection
- Excessive alcohol intake (over 21 units/week for men, 14 units/week for women)
- Pregnancy, breastfeeding, or planning pregnancy
- Participation in any other trial within the last 3 months
- Contraindications for MRI including pacemakers, defibrillators, neurostimulators, metal implants or foreign bodies
- Conditions preventing MRI such as difficulty breathing, inability to lie flat, anxiety, claustrophobia, uncontrolled hypertension, or seizure disorders severe enough to prevent MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants take daily pectin or placebo (cocoa powder) supplements for 6 weeks to study their effects on inflammation, metabolic health, and gut microbiome.
Weekly visits for up to 6 weeks
Duration - 6 weeks
Participants who agree undergo MRI scans at the start and end of treatment to assess liver fat, stiffness, and gut permeability.
2 MRI scan visits (beginning and end of treatment)
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
G
Guruprasad P Aithal, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here