Non-Alcoholic Fatty Liver Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

Main study participants:

• You have been diagnosed with a liver condition called MASLD (also known as fatty liver disease), with test results showing more than 5% fat in your liver from a scan or biopsy done recently.
• You are willing and able to sign a consent form agreeing to take part in the study.
• You are 18 years old or older, have a body mass index (BMI) between 18.5 and 39.9, and your weight has stayed roughly the same (within 3 kg) over the past 3 months.
• If you have diabetes, your blood sugar levels must be well controlled, with an HbA1c (a measure of average blood sugar) below 7.0%.
• You are able to have a FibroScan™, which is a painless liver scan used to measure liver stiffness and fat.

Healthy volunteers joining for MRI scans only:

• You are willing and able to sign a consent form agreeing to take part.
• You are 18 years old or older.
• A recent FibroScan™ (within the past 6 months) shows that your liver fat and stiffness levels are within a healthy range (confirm with trial site).

Who may not be able to join:

Main study:

• You are allergic to soya, milk, or chocolate.
• You are allergic to pectin (a substance found naturally in fruit).
• You follow a vegan diet.
• You have an eating disorder, difficulty eating, or a gut/digestive condition such as coeliac disease, irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or a condition where your stomach empties too slowly (gastroparesis).
• You have a long-term condition that causes malnutrition (not getting enough nutrients).
• You have had major surgery in the past that might make it hard for you to fully take part in or complete the study.
• You have had surgery on your intestines or gut that affects how you eat or digest food, including weight-loss (bariatric) surgery.
• You have taken antibiotics, antifungal medicines, probiotics, or prebiotics in the 90 days before the study starts.
• You are currently taking certain medications, specifically immunosuppressants (medicines that reduce your immune system), amiodarone, or perhexiline (certain heart medicines).
• You are currently following, or planning to start, a commercial weight-loss diet or programme, or are taking any weight-loss medication or herbal weight-loss products.
• You have previously had side effects from taking probiotics or prebiotics.
• You have a current or past history of a psychiatric (mental health) illness.
• You have a current or past history of a neurological condition (a condition affecting the brain or nerves), such as epilepsy.
• You have other liver problems beyond fatty liver disease.
• You have a rare inherited metabolic condition affecting how your body processes fats or other substances (confirm with trial site for specific conditions).
• Your weight has changed by more than 3 kg in the past 3 months.
• You have uncontrolled diabetes, an active cancer, or a long-term infection.
• You currently have symptoms of an active infection (such as a fever or illness).
• You drink more than 21 units of alcohol per week (if male) or more than 14 units per week (if female).
• You are pregnant, breastfeeding, or currently trying to become pregnant.
• You have taken part in another clinical trial within the last 3 months.

For the optional MRI scan part of the study (applies to both patients and healthy volunteers):

• You have a pacemaker, defibrillator, neurostimulator, certain medical implants, or metal objects in your body (such as bullets, shrapnel, or metal fragments), as these can be dangerous inside an MRI scanner.
• You have a history of a metal fragment in your eye or a penetrating eye injury.
• You have difficulty breathing, cannot lie flat, or have a condition that could be made worse by the stress of an MRI scan, such as severe claustrophobia, anxiety or panic disorders, uncontrolled high blood pressure, or seizure disorders.

Important: Always verify eligibility with the trial site directly before applying.