The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Meta… (NCT07093346) | Clinical Trial Compass
RecruitingNot Applicable
The Impact of Pectin Supplementation on Systematic Inflammation Pathway, Gut Microbiome, and Metabolic Health in Patients With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
United Kingdom45 participantsStarted 2025-06-10
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion criteria for the main study:
* 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™.
Inclusion criteria for healthy participants who will have MRI scans:
* 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.
Exclusion Criteria:
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, Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD) or gastroparesis.
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing pectin, a fiber supplement, rather than a drug — does that change the safety profile in a meaningful way for someone with my stage of MASLD, and are there any liver-related risks I should know about before considering it?
2The trial is measuring inflammation markers like TNF-alpha, IL-6, and C-reactive protein in my blood — what would it actually mean for my health if those numbers go down, and is reducing inflammation the most important goal in treating my condition right now?
3This study is listed as Phase NA, which I understand may mean it's more exploratory — how does that affect what's known about whether pectin supplementation actually improves liver health outcomes, beyond just changing blood markers?
4Since this trial is actively recruiting, what would participation look like day-to-day for me — how often would I need to come in for blood draws or check-ins, and is that realistic given my schedule and other treatments?
5Are there standard dietary or lifestyle interventions for MASLD that I should consider first, or would joining this trial be compatible with those approaches at the same time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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)).