metabolic dysfunction-associated steatotic liver disease
Conditions
Interventions
Treatment of MASLD Using a Calorie-Restricted Ketogenic Diet Strategy:Strategies for a Calorie-Restricted Ketogenic Diet
Treatment of MASLD Using an Energy-Restricted Diet Strategy:Dietary strategies that only restrict energy intake
Sponsors
The Seventh Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged between 18 and 65 years. 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). 3.Possessing basic communication skills, capable of completing questionnaires and follow-ups. 4.Capable of understanding and signing the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Populations that consume alcohol (females averaging more than 20 grams per day, males averaging more than 30 grams per day). 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). 3.Individuals diagnosed with diseases that may affect MASLD, such as viral infections (HIV, cytomegalovirus, etc.), various chronic inflammatory diseases, and connective tissue diseases. 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. 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. 6.A history of type 1 diabetes or poorly controlled type 2 diabetes. 7.Participants with difficult-to-control hypertension or dyslipidemia. 8.Participants with tumors, hematological diseases, and major cardiovascular diseases. 9.Participants who underwent bariatric surgery within one year prior to the commencement of the study. 10.Significant weight changes within three months prior to the start of the study (weight loss or gain >10% in the past three months). 11.Pregnant women, breastfeeding women, or women planning to become pregnant. 12.Participants with anticipated poor compliance. 13.Patients with mental disorders who are unable to cooperate. 14.Participants currently enrolled in other clinical trial studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement in liver fat content grading by one or more levels after a 2-month follow-up compared to baseline.; | — |
Secondary
| Measure | Time frame |
|---|---|
| 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; | — |
Countries
China
Contacts
Public ContactBin Xia
The Seventh Affiliated Hospital Sun Yat-sen University
Outcome results
None listed