A randomized controlled dietary intervention study for patients with metabolic dysfunction-associated steatotic liver disease in China
- Conditions
- metabolic dysfunction-associated steatotic liver disease
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1.Aged between 18 and 65 years.<br>2.Patients diagnosed with MASLD through abdominal ultrasound, magnetic resonance imaging, FibroScan transient elastography, or liver biopsy (according to the diagnostic criteria outlined in the 2023 multi-society Delphi consensus statement on MASLD nomenclature).<br>3.Possessing basic communication skills, capable of completing questionnaires and follow-ups.<br>4.Capable of understanding and signing the informed consent form.
1.Populations that consume alcohol (females averaging more than 20 grams per day, males averaging more than 30 grams per day).<br>2.Participants with other causes of liver steatosis or elevated transaminases (such as viral hepatitis, autoimmune liver disease, Wilson's disease, hemochromatosis, congestive liver disease, hypobetalipoproteinemia, obstructive/infectious/immune/ischemic bile duct diseases, liver cancer, liver cirrhosis, and pancreatitis).<br>3.Individuals diagnosed with diseases that may affect MASLD, such as viral infections (HIV, cytomegalovirus, etc.), various chronic inflammatory diseases, and connective tissue diseases.<br>4.The patient has taken or is currently taking medications known to promote fatty liver disease or affect its progression, including but not limited to amiodarone, steroids, methotrexate, 5-fluorouracil, irinotecan, tamoxifen, hormonal drugs, immunosuppressants, vitamin E, pirfenidone, nintedanib, pioglitazone, glucagon-like peptide-1 agonists, and SGLT2 inhibitors.<br>5.Participants who took antibiotics, metformin, or other medications that significantly affect the gut microbiota within three months prior to the start of the study or during the study period.<br>6.A history of type 1 diabetes or poorly controlled type 2 diabetes.<br>7.Participants with difficult-to-control hypertension or dyslipidemia.<br>8.Participants with tumors, hematological diseases, and major cardiovascular diseases.<br>9.Participants who underwent bariatric surgery within one year prior to the commencement of the study.<br>10.Significant weight changes within three months prior to the start of the study (weight loss or gain >10% in the past three months).<br>11.Pregnant women, breastfeeding women, or women planning to become pregnant.<br>12.Participants with anticipated poor compliance.<br>13.Patients with mental disorders who are unable to cooperate.<br>14.Participants currently enrolled in other clinical trial studies.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The improvement in liver fat content grading by one or more levels after a 2-month follow-up compared to baseline.;
- Secondary Outcome Measures
Name Time Method Change in anthropometric indicators;Changes in liver and kidney function;Changes in transient elastography;Alterations in glucose and lipid metabolism;Change in multi-omics parameters;Change in cytokines;Change in body composition;Change in visceral fat content;