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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-carbon control group | Placebo Comparator |
| |
| KD group | Experimental |
| |
| CXD and KD group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-carbon control group | Dietary Supplement | The control group received a standardized low-carbohydrate diet (carbohydrates accounted for 25%-30% of total caloric intake). |
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| Measure | Description | Time Frame |
|---|---|---|
| Controlled Attenuation Parameter (CAP) value | Use an elastography ultrasound device to measure liver fat content | From enrollment to the end of treatment at 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | From baseline to the end of the 8-week follow-up period | |
| Triglyceride(TG) | Use a fully automated biochemical analyzer to measure TG | From enrollment to the end of treatment at 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| li xing wu | Contact | 86 15856953935 | wuxingliwxl@126.com |
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| 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). |
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| 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. |
|
| Total blood cholesterol(TC) | Use a fully automated biochemical analyzer to measure TC | From enrollment to the end of treatment at 8 weeks |
| High-Density Lipoprotein(HDL) | Use a fully automated biochemical analyzer to measure HDL | From enrollment to the end of treatment at 8 weeks |
| Alanine Aminotransferase (ALT) | Use a fully automated biochemical analyzer to measure liver function | From enrollment to the end of treatment at 8 weeks |
| Aspartate Aminotransferase(AST) | Use a fully automated biochemical analyzer to measure liver function | From enrollment to the end of treatment at 8 weeks |
| Gamma-Glutamyl Transferase(GGT) | Use a fully automated biochemical analyzer to measure liver function | From enrollment to the end of treatment at 8 weeks |
| Blood glucose metabolism indicators | Use a fully automated biochemical analyzer to measure blood glucose | From enrollment to the end of treatment at 8 weeks |
| Traditional Chinese Medicine Syndrome Scoring System | The title is Traditional Chinese Medicine Syndrome Scale. The minimum score is 0 and the maximum is 6. Lower scores indicate better results. | From enrollment to the end of treatment at 8 weeks |
| Blood ketones | Use a fully automated biochemical analyzer to measure blood ketones to indicate clinical safety | From baseline to the end of the 8-week follow-up period |
| Creatinine | Use a fully automated biochemical analyzer to measure creatinine to indicate clinical safety | From enrollment to the end of treatment at 8 weeks |
| Blood Urea Nitrogen | Use a fully automated biochemical analyzer to measure blood urea nitrogen to indicate clinical safety | From enrollment to the end of treatment at 8 weeks |