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:

• People aged between 20 and 70 years old (male or female)
• People who have been diagnosed with liver fat accumulation through a specific scan called FibroScan, with a result of CAP 260 or higher
• People who also meet at least one of the following conditions:
• A body mass index (BMI) of 23 or higher, or a waist measurement of 90cm or more (men) / 80cm or more (women)
• A fasting blood sugar level of 100 mg/dL or higher, a blood sugar level of 140 mg/dL or higher after eating, an HbA1c (a measure of average blood sugar) of 5.7 or higher, or a diagnosis of type 2 diabetes (whether currently being treated or not)
• A blood pressure reading of 130/80 mmHg or higher, or currently taking blood pressure medication
• A blood triglyceride (a type of fat in the blood) level of 150 mg/dL or higher, or currently taking medication for this
• An HDL ("good") cholesterol level of 40 mg/dL or lower (men) or 50 mg/dL or lower (women), or currently taking medication for this
• Women who are able to become pregnant must agree to use at least two forms of contraception during the trial
• People who are willing and able to sign a consent form and follow all trial requirements
• People who agree to attend all required follow-up appointments and to collect, store, and deliver stool samples as instructed by the trial team

Who may not be able to join:

• People who are pregnant or breastfeeding
• People who have used probiotic or prebiotic supplements in the 14 days before the first trial visit
• People who have taken antibiotic or antifungal medications (other than creams or ointments applied to the skin) in the 30 days before the first trial visit
• People who have taken certain medications that could affect the trial measurements in the 14 days before the first trial visit — including steroids, immune-suppressing drugs, anti-inflammatory drugs, or medications related to hepatitis, cholesterol, or metabolism. Note: Some specific medications are allowed (such as Metformin, Statins, GLP-1 RAs, SGLT2 inhibitors, and several others), particularly if they have been taken continuously for more than six months at the same dose (confirm with trial site)
• People who currently have significant diarrhoea caused by an infection (defined as loose stools more than three times in a 24-hour period)
• People who have been diagnosed with severe liver disease, a condition that significantly affects liver function, or active inflammatory bowel disease
• People with acute hepatitis (caused by a virus or other cause) and a liver enzyme reading (ALT) above 200 U/L
• People who have had a coronary artery stent procedure within the past six months
• People with a fasting blood sugar level of 300 mg/dL or higher, or an HbA1c above 9%
• People with a blood triglyceride level of 500 mg/dL or higher
• People who have taken part in another clinical study involving investigational drugs, medical devices, functional foods, or cosmetics within the 30 days before the first trial visit
• People who have followed a formal weight-loss programme within the 60 days before the first trial visit
• People who have travelled overseas for 10 or more days within the 60 days before the first trial visit, or who plan to travel overseas during the study
• People who follow a special or restricted diet (confirm with trial site for specific details)
• People considered by the trial doctor to be unsuitable for the trial for any reason

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