An observational study in Obesity & Overweight, Diabete Type 2 and Metabolic Syndrome, sponsored by The Seventh Affiliated Hospital of Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 14 Years to 72 Years. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by The Seventh Affiliated Hospital of Sun Yat-sen University · Observational
This is a retrospective study using existing medical records. The purpose is to learn how Traditional Chinese Medicine (TCM) fasting therapy affects metabolism. The study also examines whether a substance called beta-hydroxybutyrate (βHB), which is produced during fasting, is related to improvements in metabolic health.
The researchers will review records of patients who previously received TCM fasting therapy. Patients will be divided into three groups based on how much their βHB levels increased after therapy (low, medium, and high). The study will compare changes in metabolic health measures, such as body weight, BMI, waist size, blood pressure, blood sugar, and blood fats, before and after therapy. It will also analyze whether greater increases in βHB are linked to greater improvements in these metabolic measures, while taking into account factors like age, sex, and baseline BMI.
This study does not involve any new tests or treatments. It only uses data that already exist in patient records. The findings may help doctors better understand how TCM fasting therapy works and whether βHB could be a useful marker for guiding treatment in the future.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 1,149 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →The Seventh Affiliated Hospital of Sun Yat-sen University is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
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Patients with overweight/obesity or metabolism-related conditions who received structured Traditional Chinese Medicine (TCM) fasting therapy at The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen) between [起始年份] and [结束年份], and whose medical records contain serum beta-hydroxybutyrate (βHB) measurements before and after therapy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A structured Traditional Chinese Medicine (TCM) fasting therapy based on Bigu principles, typically lasting 9 days (1-day buffer, 5-day fasting, 3-day recovery). During the fasting phase, daily caloric intake is strictly restricted, and TCM herbal formulas (modified Linggui Zhugan Decoction) are administered to alleviate hunger and fatigue. The therapy integrates TCM herbal medicine with controlled fasting to induce a ketogenic state.
Correlation between changes in serum beta-hydroxybutyrate (βHB) and changes in metabolic indicators
The primary outcome is the correlation between the change in serum beta-hydroxybutyrate (βHB) levels from baseline (before TCM fasting therapy) to completion of TCM fasting therapy (average 7 days) and the concurrent changes in key metabolic indicators (including body weight, BMI, waist circumference, blood pressure, lipid profile, and glycemic indices). This will be assessed using partial correlation analysis, controlling for baseline age, sex, and BMI.
Time frame: Baseline and at completion of TCM fasting therapy, an average of 7 days
Correlation between increase in serum beta-hydroxybutyrate (βHB) and improvement in metabolic indicators
The primary outcome is the correlation between the change in serum beta-hydroxybutyrate (βHB) levels from baseline to post-TCM fasting therapy and the concurrent changes in key metabolic indicators (including body weight, BMI, waist circumference, blood pressure, lipid profile, and glycemic indices). This will be assessed using partial correlation analysis, controlling for baseline age, sex, and BMI.
Time frame: Baseline and post-intervention , an average of 7 days
Plan to share: No — Individual participant data will not be shared because the data were collected retrospectively from medical records without specific consent for data sharing
No publications or documents are linked to this record.
Ran from Aug 2026 to primary completion in Aug 2026, 0 months.
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The Seventh Affiliated Hospital of Sun Yat-sen University