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Nonalcoholic Fatty Liver DiseasePEC-MASLDNCT07093346

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 study testing Pectin, Cocoa Powder and Magnetic Resonance Imaging with Contrast in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Fatty Liver Disease (NAFLD), run by University of Nottingham at 3 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Pectin, Cocoa Powder and Magnetic Resonance Imaging with Contrast
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
3 sitesUnited Kingdom
Study dates
10 Jun 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
  • Have chronic malnutrition condition.
  • History of major surgery which potentially limits participation or completion of the study.
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  • History of previous intestinal surgery known to affect food intake or digestive function, including bariatric surgery.
  • Use of antibiotics, antifungal medications, probiotics or prebiotics 90 days before the start of the study.
  • Are taking the following medications: immunosuppressants, amiodarone and/or perhexiline.
  • Are currently following or anticipated to commence a specialised commercially available weight loss diet and/or program or concomitant use of any weight loss medication or herbal weight loss products.
  • History of side effects towards probiotics or prebiotics.
  • History or current psychiatric illness.
  • History or current neurological condition (e.g. epilepsy).
  • Participants with other liver abnormalities.
  • Evidence of monogenic metabolism diseases such as Lysosomal acid lipase deficiency (LALD), Wilson disease, Hypobetalipoproteinemia, or inborn errors of metabolism.
  • Have had a weight change exceeding 3 kg within 3 months.
  • Uncontrolled diabetes, active malignancy, or chronic infections.
  • Having symptoms of active infection.
  • Excessive alcohol intake defined as self-reported intakes greater than 21 units per week in men, and 14 units per week in women.
  • Participants who are pregnant, breast feeding or actively planning pregnancy will be excluded from the study.
  • Participation in any other trial in the last 3 months.
  • Exclusion criteria for healthy volunteers MRI scans and patients optional MRI scans:
  • Contraindications for MRI scanning: having pacemakers, defibrillators, neurostimulators, prohibited medical implants, and foreign bodies (e.g. bullets, shrapnel, metal slivers), history of metallic foreign body in eye(s) and penetrating eye injury that could present a risk during an MRI scan.
  • Difficulty breathing or inability to lie flat, as well as conditions that could worsen under stress (such as anxiety or panic disorders, claustrophobia, uncontrolled hypertension, or seizure disorders) severe enough to prevent undergoing an MRI.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Noor K Al-Tameemi, PhD student candidate contact

0044 01158231149

noorkifahabdulhussein.al-tameemi@nottingham.ac.uk

Guruprasad P Aithal, Professor contact

0044 01158231149

guru.aithal@nottingham.ac.uk

United Kingdom3 sites, 3 recruiting

  • University of Nottingham

    Nottingham, United Kingdom, NG7 2UH

    Noor K Al-Tameemi, PhD student candidate, 0044 01158231149, noorkifahabdulhussein.al-tameemi@nottingham.ac.uk

    Guruprasad P Aithal, Professor, 0044 01158231149, guru.aithal@nuh.nhs.uk

    Recruiting

  • Sir Peter Mansfield Imaging Centre, University of Nottingham

    Nottingham, NG7 2QX

    Noor K Al-Tameemi, PhD student candidate, 0044 01158231149, noorkifahabdulhussein.al-tameemi@nottingham.ac.uk

    Guruprasad P Aithal, Professor, 0044 01158231149, guru.aithal@nottingham.ac.uk

    Recruiting

  • Nottingham Clinical Research Facility at Nottingham University Hospitals NHS Trust

    Nottingham, NG7 2UH

    Noor K Al-Tameemi, PhD student candidate, 0044 01158231149, noorkifahabdulhussein.al-tameemi@nottingham.ac.uk

    Guruprasad P Aithal, Professor, 0044 01158231149, guru.aithal@nottingham.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

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): A Randomised, Placebo-Controlled, Dietary Intervention Study

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?

Read more

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
Read the detailed description

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.
Being tested
Pectin, Cocoa Powder, Magnetic Resonance Imaging with Contrast
Keywords
LM pectin, pectin, MASLD, NAFLD, Nonalcoholic Fatty Liver Disease, Systemic Inflammatory Response, Dietary Fiber, Dietary Fibre, Diet, gut microbiota, Metabolic Dysfunction-Associated Steatotic Liver Disease
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PectinDietary supplement

    15g of pectin with 10g of cocoa powder added as flavour were randomly allocated to eligible participants.

  • Cocoa PowderOther

    10g of cocoa powder served as the control/ placebo to compare the effects observed with pectin.

  • Magnetic Resonance Imaging with ContrastDiagnostic test

    Also called MRI

    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.

Study groups in NCT07093346
Study groupRoleWhat they receive
PectinActive comparator15g/day of pectin with 10g/day of cocoa powder added as flavour will be provided to participants for 6 weeks.
Receives: Dietary Supplement: Pectin
Cocoa PowderPlacebo comparator10g/day of cocoa powder will be provided to participants for 6 weeks.
Receives: Other: Cocoa Powder
Magnetic resonance imaging (MRI) ValidationOtherTo 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.
Receives: Diagnostic Test: Magnetic Resonance Imaging with Contrast

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)).

    Change in circulating markers of inflammation measured by ELISAs in serum samples collected pre and post the 6-weeks intervention period.

    Measured: 6 weeks

Secondary outcomes (11)

  1. Change in BMI (kg/m²)

    Changes in BMI pre and post the 6-weeks intervention period.

    Measured: 6 weeks

  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)

    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) pre and post the 6-weeks intervention period.

    Measured: 6 weeks

  3. Assessment of changes in 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.

    Changes in 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 pre and post the 6-weeks intervention period.

    Measured: 6 weeks

  4. Change in Liver Stiffness via Transient Elastography

    CAP and liver stiffness (in kPa) measured using transient elastography.

    Measured: 6 weeks

  5. Change in Liver Fat Fraction Assessed by Dixon MRI Sequence.

    Fat fraction (%) in liver and abdominal organs assessed using Dixon MRI before and after the 6-week intervention.

    Measured: 6 weeks

  6. Change in Intestinal Permeability Measured by T2* MRI.

    T2* values in gut wall tissue will be compared before and after the intervention as a proxy for gut permeability.

    Measured: 6 weeks

  7. Investigation the presence of gene variants such as MUC2, encoding Mucin protein, that are associated with gut permeability.

    Genetic variants such as MUC2 will be determined where consent for genetic analysis is given.

    Measured: 6 weeks

  8. Change in Systolic Blood Pressure (mmHg)

    Change in Systolic Blood Pressure (mmHg) before and after the 6-week intervention.

    Measured: 6 weeks

  9. Change in Diastolic Blood Pressure (mmHg)

    Change in Diastolic Blood Pressure (mmHg) before and after the 6-week intervention.

    Measured: 6 weeks

  10. Change in Heart Rate (beats/minute)

    Change in Heart Rate (beats/minute) before and after the 6-week intervention.

    Measured: 6 weeks

  11. Change in Waist-to-Hip Ratio

    Change in Waist-to-Hip Ratio before and after the 6-week intervention.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2025
  2. Study start10 Jun 2025
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will be a parallel design, placebo-controlled, randomised dietary intervention study in which each participant will be randomly assigned to either pectin supplementation arm or control arm using online software (sealedenvelope.com).
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07093346
Sponsor's protocol ID
24076
Other IDs
351797
Acronym
PEC-MASLD
Status last verified
Jul 2026
First submitted
8 Jul 2025
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Al-Tameemi NK, Grove JI, Hoad CL, Wai JWS, Olaru A, Mandal S, Rollins KE, Bradley CR, Francis ST, Gowland PA, Valdes AM, Aithal GP. The impact of pectin supplementation on systemic inflammation pathways, gut microbiome, and metabolic health in patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A study protocol for a randomised controlled trial. PLoS One. 2026 Jul 13;21(7):e0352397. doi: 10.1371/journal.pone.0352397. eCollection 2026.

    PubMed 42441559

Questions about this trial

What is this clinical trial studying?

A study testing Pectin, Cocoa Powder and Magnetic Resonance Imaging with Contrast in people with Nonalcoholic Fatty Liver Disease and Nonalcoholic Fatty Liver Disease (NAFLD), run by University of Nottingham at 3 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Noor K Al-Tameemi, PhD student candidate (0044 01158231149, noorkifahabdulhussein.al-tameemi@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07093346, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.

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