Traditional Chinese Medicine Fasting Therapy, Ketone Levels, and Metabolic Improvements

Overall Objective:

The overall objective of this study is to investigate the correlation between the elevation of serum beta-hydroxybutyrate (βHB) after Traditional Chinese Medicine (TCM) fasting therapy and the improvement of metabolic indicators, and to clarify whether βHB can serve as a potential biomarker for the metabolic effects of TCM fasting therapy, thereby providing clinical evidence for the metabolic regulatory mechanism of TCM fasting therapy.

Specific Objectives:

Baseline characteristics analysis: Using a three-category approach, enrolled cases will be divided into low, medium, and high groups based on the degree of βHB elevation after TCM fasting therapy. Baseline demographic characteristics and metabolic indicators (body weight, BMI, waist circumference, blood pressure, lipid profile, and glycemic indices) will be compared among the three groups to identify the baseline characteristics of populations with different βHB responses.

Intervention effect evaluation: To compare the overall changes in the above metabolic indicators before and after TCM fasting therapy, and to evaluate the comprehensive improvement effect of TCM fasting therapy in patients with overweight/obesity and metabolism-related diseases.

Correlation analysis: For metabolic indicators that show statistically significant changes before and after intervention, partial correlation analysis will be used to analyze the correlation between the change values of each indicator and the increase in βHB, after controlling for baseline confounders such as age, sex, and BMI.

Independent association exploration: Multiple linear regression models will be constructed, incorporating potential confounders (age, sex, baseline BMI, baseline metabolic indicator levels, comorbidities, etc.), to verify whether there is an independent association between the metabolic improvement induced by TCM fasting therapy and the elevation of βHB.

Sensitivity analysis: Subgroup analyses (e.g., stratified by obesity degree, metabolic status, age, and sex) will be performed to test the robustness of the above associations.

Overall Hypothesis:

The overall hypothesis is that TCM fasting therapy improves metabolic indicators in patients with overweight/obesity and metabolism-related diseases by inducing a ketogenic state and elevating serum βHB levels; the degree of serum βHB elevation is positively correlated with the extent of metabolic improvement.

Specific Hypotheses:

Baseline difference hypothesis: There are significant differences in baseline metabolic indicators among groups with different degrees of βHB elevation. Patients with more severe baseline metabolic disturbances (e.g., higher BMI, larger waist circumference, more obvious abnormal glucose/lipid levels) may experience more significant βHB elevation after intervention.

Intervention effect hypothesis: After TCM fasting therapy, metabolic-related indicators such as body weight, BMI, waist circumference, blood pressure, lipids (TC, TG, LDL-C), fasting blood glucose, liver function (ALT, AST, GGT), and inflammatory markers (CRP) will be significantly improved compared with baseline.

Correlation hypothesis: After adjusting for baseline confounders, there is a significant partial correlation between the increase in serum βHB and the improvement values of the above metabolic indicators. The more significant the increase in βHB, the more obvious the improvement in metabolic indicators.

Independent association hypothesis: After controlling for potential confounders such as age, sex, baseline BMI, baseline metabolic levels, and comorbidities, there is an independent, dose-dependent positive correlation between βHB elevation and TCM fasting therapy-induced metabolic improvement.

Robustness hypothesis: The above associations remain consistent across different subgroups (e.g., different degrees of obesity, different metabolic states, different age groups, and different sexes), and sensitivity analyses support the robustness of the main analysis results.

Significance:

This study aims to preliminarily explore whether the mechanism by which TCM fasting therapy improves metabolism is related to ketogenic status and βHB elevation through retrospective case analysis. The results will provide a new mechanistic explanation for the clinical application of TCM fasting therapy, provide evidence-based medical basis for optimizing TCM fasting therapy regimens (e.g., guiding individualized treatment by monitoring βHB levels), and lay the foundation for further prospective mechanistic studies.

Inclusion criteria

• Male or female patients aged 18 years or older at the time of receiving TCM fasting therapy.
• Diagnosed with overweight/obesity or a metabolism-related condition (e.g., overweight/obesity, metabolic syndrome, type 2 diabetes mellitus, dyslipidemia, or hypertension).
• Received a structured Traditional Chinese Medicine (TCM) fasting therapy at The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen).
• Serum beta-hydroxybutyrate (βHB) levels were measured before and after TCM fasting therapy.
• Availability of complete medical records containing baseline and post-therapy data on key metabolic indicators (body weight, BMI, waist circumference, blood pressure, lipid profile, and glycemic indices).

Exclusion criteria

• Patients with incomplete medical records lacking essential baseline or post-therapy metabolic data.
• Patients with severe comorbidities that could independently affect metabolic outcomes (e.g., active malignancy, severe hepatic or renal insufficiency, or uncontrolled endocrine disorders other than the conditions being studied).
• Patients who received other concurrent interventions that could significantly confound metabolic outcomes during the study period.
• Pregnant or lactating women.
• Patients whose medical records explicitly indicate refusal of data use for research purposes.