Combination of CXD and Restrictive Ketogenic Diet Against MASLD

Official title

Clinical Trial Study on the Combination of CXD and Restrictive Ketogenic Diet in Treating MASLD

Overview

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 supplement Low-carbon control group
  The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).
• Dietary supplement KD group
  Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).
• Drug CXD 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.

Primary outcome measures

• Controlled Attenuation Parameter (CAP) value [Time frame: From enrollment to the end of treatment at 8 weeks]

Secondary outcome measures (12)

• BMI [Time frame: From baseline to the end of the 8-week follow-up period]
• Triglyceride(TG) [Time frame: From enrollment to the end of treatment at 8 weeks]
• Total blood cholesterol(TC) [Time frame: From enrollment to the end of treatment at 8 weeks]
• High-Density Lipoprotein(HDL) [Time frame: From enrollment to the end of treatment at 8 weeks]
• Alanine Aminotransferase (ALT) [Time frame: From enrollment to the end of treatment at 8 weeks]
• Aspartate Aminotransferase(AST) [Time frame: From enrollment to the end of treatment at 8 weeks]
• Gamma-Glutamyl Transferase(GGT) [Time frame: From enrollment to the end of treatment at 8 weeks]
• Blood glucose metabolism indicators [Time frame: From enrollment to the end of treatment at 8 weeks]
• Traditional Chinese Medicine Syndrome Scoring System [Time frame: From enrollment to the end of treatment at 8 weeks]
• Blood ketones [Time frame: From baseline to the end of the 8-week follow-up period]
• Creatinine [Time frame: From enrollment to the end of treatment at 8 weeks]
• Blood Urea Nitrogen [Time frame: From enrollment to the end of treatment at 8 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07639866 · KD20260527

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗