MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
Conditions
Brief summary
This study employed a single-center, randomized, investigator-blind, three-group parallel, stepwise controlled clinical trial. A total of 135 subjects were randomly assigned to receive either a low-carbohydrate diet intervention, a restrictive ketogenic diet intervention, or a decoction preparation of the Tucha Lipid-Reducing Formula combined with a restrictive ketogenic diet. The trial duration consisted of 8 weeks of treatment followed by 8 weeks of follow-up. During the trial, participants adhered to dietary calorie control and moderate exercise as instructed in health education, self-reported their height, weight, waist-to-hip ratio, and other general parameters, and had weekly blood ketone level monitoring. Liver ultrasound, fasting blood glucose, lipid profiles, blood ketones, liver function tests, serum creatinine, urea nitrogen levels, and scores on the Traditional Chinese Medicine Syndrome Scale were measured before treatment initiation and at the end of the 8-week treatment period.
Interventions
DIETARY_SUPPLEMENTLow-carbon control group
The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).
DIETARY_SUPPLEMENTKD group
Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).
DRUGCXD and KD group
In addition to a restrictive ketogenic diet intervention, the patients were administered a traditional Chinese medicine compound formula named Chazhu Xiaoli Formula for lipid reduction. Below is the composition of Chazhu Xiaozhi decoction: Camellia Sinensis Radix 15g, Atractylodis Rhizoma 15g, Herba Gynostemmatis Pentaphylli 15g, Ilicis Cornutae Folium 15g, Alismatis Rhizoma 9g, Nelumbinis Folium 6g, Crataegi Fructus 6g, Polygoni Orientalis Fructus 3g.
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-50 years, regardless of gender * Meet the diagnostic criteria for MASLD * Meet the diagnostic criteria for dampness-heat accumulation syndrome in Traditional Chinese Medicine * Liver controlled attenuation parameter (CAP) ≥238 dB/m * Body mass index (BMI) ≥23 kg/m² * Possess adequate cognitive and comprehension abilities to understand the study content, its potential risks, and benefits; * Voluntarily participate in this study and personally sign the informed consent form
Exclusion criteria
* Concurrent presence of other liver diseases that may lead to hepatic steatosis, specifically including drug-induced liver injury, alcoholic liver disease, autoimmune liver disease, viral hepatitis, and Wilson's disease * Concurrent severe dysfunction of major organs such as the heart, kidneys, or lungs, e.g., severe cardiac insufficiency (NYHA class III or higher), renal failure (estimated glomerular filtration rate \<30 mL/min/1.73 m²), or acute exacerbation of chronic obstructive pulmonary disease * Subjects currently receiving treatment for MASLD * Concurrent presence of other severe systemic diseases, such as malignant tumors or active systemic lupus erythematosus * Known hypersensitivity or intolerance to any component of the study drug * Pregnant women, lactating women, or women of childbearing age who refuse effective contraceptive measures during the trial * Participation in other clinical trials within the past 3 months * Other circumstances deemed by the investigator unsuitable for participation in this study, such as severe mental disorders affecting compliance with the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Controlled Attenuation Parameter (CAP) value | From enrollment to the end of treatment at 8 weeks | Use an elastography ultrasound device to measure liver fat content |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BMI | From baseline to the end of the 8-week follow-up period | — |
| Triglyceride(TG) | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure TG |
| Total blood cholesterol(TC) | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure TC |
| High-Density Lipoprotein(HDL) | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure HDL |
| Alanine Aminotransferase (ALT) | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure liver function |
| Aspartate Aminotransferase(AST) | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure liver function |
| Gamma-Glutamyl Transferase(GGT) | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure liver function |
| Blood glucose metabolism indicators | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure blood glucose |
| Traditional Chinese Medicine Syndrome Scoring System | From enrollment to the end of treatment at 8 weeks | The title is Traditional Chinese Medicine Syndrome Scale. The minimum score is 0 and the maximum is 6. Lower scores indicate better results. |
| Blood ketones | From baseline to the end of the 8-week follow-up period | Use a fully automated biochemical analyzer to measure blood ketones to indicate clinical safety |
| Creatinine | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure creatinine to indicate clinical safety |
| Blood Urea Nitrogen | From enrollment to the end of treatment at 8 weeks | Use a fully automated biochemical analyzer to measure blood urea nitrogen to indicate clinical safety |
Contacts
CONTACTli xing wu
Outcome results
None listed