BridgeMD
New treatment option for Nonalcoholic Fatty Liver Disease
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)
ClinicalTrials.gov ID: NCT07093346
What this study is testing
- What it's testing
- 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?
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- for the main study:
- Patients with clinical diagnosis of MASLD (formerly termed non-alcoholic fatty liver disease (NAFLD)), having assessment suggesting that liver fat \>...
- 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...
- For diabetic participants: controlled blood glucose levels Haemoglobin A1C (HbA1c) \<7.0% (\<53 mmol/mol) [1].
You likely can't join if
- 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...
- Have chronic malnutrition condition.
See the full eligibility 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...
- 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™. 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 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.
- Have chronic malnutrition condition.
- History of major surgery which potentially limits participation or completion of the study.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Nottingham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nottingham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.