Obesity
Conditions
Interventions
Treatment group:XOWi-based Weight Loss Intervention with Adjunctive Umbilical Acupuncture
Control group:"XOWi Weight Management Plan + Recommended Acupuncture Plan from the Expert Consensus on TCM Diagnosis and Treatment of Obesity (2022)"
Sponsors
Shanghai Municipal Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Age 18-65 years; Meets the diagnostic criteria for simple obesity; Conforming to the diagnostic criteria of TCM syndrome elements Weight loss of < 5 kg within the last three months; Provision of voluntary written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria included: 1. Secondary obesity caused by endocrine disorders (e.g. hypothyroidism Cushing's syndrome polycystic ovary syndrome)12; 2. Glycemic abnormalities defined as HbA1c >6.5% and/or fasting plasma glucose =7 mmol/L and/or 2-hour postprandial glucose =11.1 mmol/L; 3. Use of weight-impacting medications (glucocorticoids antiepileptic drugs psychotropic medications) within the past 3 months; 4. Current or recent (past 3 months) use of gut microbiota-modulating agents (antibiotics probiotic supplements NSAIDs proton pump inhibitors immunosuppressants); 5. Severe comorbidities including cardiovascular/cerebrovascular diseases hematologic disorders psychiatric illnesses or malignancies; 6. Significant hepatic/renal dysfunction (ALT/AST exceeding 2.5 times upper limit of normal; glomerular filtration rate <30 mL/min/1.73 m²); 7. Pregnancy lactation or planned pregnancy; 8. Participation in other clinical trials involving investigational drugs/devices within the past 3 months; 9. Previous weight loss interventions within the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Body Weight Loss;Proportion of Subjects Achieving =5% Weight Loss; | — |
Secondary
| Measure | Time frame |
|---|---|
| Insulin resistance (Fasting serum insulin, fasting serum C- peptide, HOMA2-IR );Proportion of Subjects Achieving =10% Weight Loss;Changes in body composition (Waist circumference, Waist-Hip-Ratio, body fat percentage, body fat mass, trunk fat percentage, limb muscle mass percentage);Peptide, PYY;Body Fat Percentage (BFP);Body Mass Index(BMI); triglyceride, TG;rs-fMRI;low-density lipoprotein cholesterol (LDL-C);Ghrelin;total cholesterol, TC;Cholecystokinin (CCK);Three-Factor Eating Questionnaire (TFEQ);Gut microbiota;Appetite Visual Analog (VAS);Basal Metabolic Rate (BMR);Waist Circumference (WC);Syndrome Element Analysis in TCM;high-density lipoprotein cholesterol, HDL-C;Food Cravings Questionnaire- Trait (FCQ-T); | — |
Countries
China
Contacts
Public ContactFENG TAO
Shanghai Municipal Hospital of Traditional Chinese Medicine?
Outcome results
None listed