Obesity
Conditions
Interventions
Observation Group:taVNS+lifestyle modification
Control Goup:sham taVNS+lifestyle modification
Sponsors
Hubei Provincial Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: (1) meet the diagnostic criteria of obesity (body mass index =28.0 kg/m2); (2) age 18-50 years old right-handed; (3) senior high school or above can cooperate to complete the questionnaire; (4) no metal implants claustrophobia and other contraindications to MRI examination; (5) ECG results were normal; (6) not taking any drugs that may affect intestinal microbes in the past 3 months such as lactacin tablets and Silian Kang Zhengchangsheng Bifidobacterium tetragenous viable bacteria tablets; (7) sign the informed consent form and voluntarily participate in the project.
Exclusion criteria
Exclusion criteria: (1) Secondary obesity caused by hypothyroidism Cushing's syndrome hyperadrenocortical function polycystic ovary syndrome etc.; (2) Using drugs that have a significant effect on body weight within 3 months: hormonal drugs (glucocorticoids (such as dexamethasone hydrocortisone prednisone methylprednisolone etc.) sex hormones growth hormones etc.) antipsychotic drugs antidepressants antiepileptic drugs hormonal contraceptives; (3) surgical or device intervention (e.g. gastric banding intragastric balloon) with a history of obesity or planned surgery within 6 months; (4) have received within 3 months or are receiving weight-loss treatment including medications (e.g. orlistat metformin semaglutide) and organized weight-loss training camps; (5) weight change > 5 kg within 3 months; (6) with mental disorders or previous history of schizophrenia depression somatization disorder history of suicidal behavior or diagnosed with eating disorders (buliphagia anorexia etc.) or long-term use of antipsychotic drugs; (7) with serious diseases of the heart lung brain liver or kidney (including but not limited to persistent renal or hepatic insufficiency congestive heart failure unstable angina pectoris myocardial infarction or stroke within the past six months) or hematopoietic system diseases progressive malignant tumors or other serious wasting diseases; (8) magnetic resonance imaging showed cerebral vascular disease epilepsy tumor or other organic lesions; (9) Mini-Mental State Examination score indicating cognitive impairment; (10) pregnant breastfeeding or planning to become pregnant in the next six months; (11) participated in other clinical trials within six months; (12) ear skin infection damage and other reasons not suitable for taVNS; (13) received taVNS intervention within the past 3 months; (14) Other reasons: According to the investigator's judgment the subjects were unlikely to comply with the protocol or were not suitable for any reason such as frequent and long time travel.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage change of body weight from baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| behavioral experiment;change of waist circumference from baseline;TCM body constitution types assessment;percentage of subjects who lost more than 7% of their body weight from baseline;HRV;clinical scale assessment;change of hip circumference from baseline;intestinal microbiota;change of body mass index from baseline;brain-gut peptide;percentage of subjects who lost more than 5% of their body weight from baseline;percentage change of body fat from baseline;change of visceral fat area from baseline;fMRI; | — |
Countries
China
Contacts
Public ContactZhou Zhongyu
Hubei Provincial Hospital of Traditional Chinese Medicine
Outcome results
None listed