Combination of CXD and Restrictive Ketogenic Diet Against MASLD

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-50
SponsorShanghai Municipal Hospital of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Low-carbon control group
  • KD group
  • CXD and KD group

Treatment groups

135 Participants
are divided into 3 treatment groups

Locations

This trial has no locations