Health TrialsbyHealthPanel

Combination of CXD and Restrictive Ketogenic Diet Against MASLD

ConditionMASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Low-carbon control group

    Dietary supplement

    The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake).

  • KD group

    Dietary supplement

    Daily carbohydrate intake should not exceed 5%, with three consecutive ketogenic days per week implemented (selected according to the subject's preference).

  • CXD and KD group

    Drug

    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.

Treatment groups

135 Participants
are divided into 3 treatment groups
Group A: Low-carbon control groupPlacebo comparator 1 intervention
Group B: KD groupExperimental treatment 1 intervention
Group C: CXD and KD groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Controlled Attenuation Parameter (CAP) value

Use an elastography ultrasound device to measure liver fat content

Time frame
From enrollment to the end of treatment at 8 weeks

Secondary outcomes

1

BMI

Time frame
From baseline to the end of the 8-week follow-up period
2

Triglyceride(TG)

Use a fully automated biochemical analyzer to measure TG

Time frame
From enrollment to the end of treatment at 8 weeks
3

Total blood cholesterol(TC)

Use a fully automated biochemical analyzer to measure TC

Time frame
From enrollment to the end of treatment at 8 weeks
4

High-Density Lipoprotein(HDL)

Use a fully automated biochemical analyzer to measure HDL

Time frame
From enrollment to the end of treatment at 8 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Municipal Hospital of Traditional Chinese Medicine

Lead sponsor

Source ClinicalTrials.gov

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