Obesity & OverweightNCT07840807
Traditional Chinese Medicine Fasting Therapy, Ketone Levels, and Metabolic Improvements
An observational study of Obesity & Overweight and Diabete Type 2, run by The Seventh Affiliated Hospital of Sun Yat-sen University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 72 years
- Conditions the study is for
- Obesity & Overweight, Diabete Type 2, Metabolic Syndrome
- What is being tested?
- Traditional Chinese Medicine Fasting Therapy
- How many people
- 1,149 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 72 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen)
Shenzhen, Guangdong, 518107
About this study
Official title: Effects of Traditional Chinese Medicine Fasting Therapy on Metabolism and the Relationship Between Therapy-Induced Beta-Hydroxybutyrate Elevation and Metabolic Improvement: A Retrospective Clinical Study
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.
Read the detailed description
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.
- Conditions
- Obesity & Overweight, Diabete Type 2, Metabolic Syndrome
- Being tested
- Traditional Chinese Medicine Fasting Therapy
- Keywords
- Traditional Chinese Medicine Fasting, Beta-Hydroxybutyrate, Metabolic Improvement, Retrospective Study
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus, Type 2, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional Chinese Medicine Fasting TherapyOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and post-intervention , an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study start1 Aug 2026
- Primary completion30 Aug 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,149 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Seventh Affiliated Hospital of Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Ling, The Seventh Affiliated Hospital of Sun Yat-sen University
- Investigators
- Jian Qin, PhD, Principal investigator, The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840807
- Sponsor's protocol ID
- KY-2026-238-01
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the data were collected retrospectively from medical records without specific consent for data sharing
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Traditional Chinese Medicine Fasting Therapy on Metabolism and the Relationship Between Therapy-Induced Beta-Hydroxybutyrate Elevation and Metabolic Improvement: A Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT07840807
- Acronym / sponsor ID
- KY-2026-238-01
- Conditions
- Obesity & Overweight, Diabete Type 2, Metabolic Syndrome
- Keywords
- Traditional Chinese Medicine Fasting, Beta-Hydroxybutyrate, Metabolic Improvement, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,149 participants (actual)
- Lead sponsor
- The Seventh Affiliated Hospital of Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Aug 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 25 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 14 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Chinese Medicine Fasting TherapyA 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. | Other | – |
Primary outcome
Correlation between changes in serum beta-hydroxybutyrate (βHB) and changes in metabolic indicators
Time frame: Baseline and at completion of TCM fasting therapy, an average of 7 days
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.
Correlation between increase in serum beta-hydroxybutyrate (βHB) and improvement in metabolic indicators
Time frame: Baseline and post-intervention , an average of 7 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the data were collected retrospectively from medical records without specific consent for data sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Qin, PhD principal investigator
The Seventh Affiliated Hospital, Sun Yat-sen University (Shenzhen)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and Diabete Type 2, run by The Seventh Affiliated Hospital of Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between changes in serum beta-hydroxybutyrate (βHB) and changes in metabolic indicators (time frame: Baseline and at completion of TCM fasting therapy, an average of 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.