Overweight/Obesity
Conditions
Interventions
Sponsors
Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria for Healthy Volunteers: (1) Individuals with normal body weight (18.5 = BMI = 28.0 kg/m² (obesity) or 24.0 kg/m² <= BMI < 28.0 kg/m² (overweight); (2) Treatment history: No use of GLP-1 receptor agonists, insulin, or weight-loss surgery within 3 months prior to screening; (3) Gut microbiota status: No recent (within 6 months) history of antibiotic or probiotic use; (4) Voluntary participation in the study and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Healthy Volunteers: (1) Individuals with severe organic diseases or chronic conditions affecting the heart, liver, kidneys, hematopoietic system, etc.; (2) Use of medications affecting body weight, blood sugar, blood lipids, or other related indicators within the past 3 months; (3) Pregnancy; (4) History of bariatric surgery; (5) Inability to undergo physical function tests or to answer questionnaire questions correctly; (6) Inability to comply with the trial procedures; (7) Allergy to any ingredient of the investigational product; (8) Refusal to sign the informed consent form; (9) Use of weight-loss medications, anti-anxiety or antidepressant medications, or receipt of weight-loss treatment from a nutritionist within the past 3 months. Exclusion Criteria for Overweight/Obese Patients: (1) Comorbid conditions: Severe hepatic or renal insufficiency, inflammatory bowel disease, immunodeficiency, or active malignancy; (2) Medication interference: Long-term use of glucocorticoids, immunosuppressants, or medications affecting gastrointestinal motility (e.g., orlistat); (3) Pregnancy; (4) Allergy history: Allergy to Escherichia coli or components of the engineered bacterial vector; (5) Use of medications affecting body weight, blood sugar, blood lipids, or other related indicators within the past 3 months; (6) Inability to undergo physical function tests or to answer questionnaire questions correctly; (7) Inability to comply with the trial procedures; (8) Allergy to any ingredient of the investigational product; (9) Refusal to sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight;Body Mass Index, BMI;Waist-to-Hip Ratio;Gut Microbiota Sequencing;Fecal/Blood Metabolome Sequencing;Fasting blood sugar;Liver function 5 tests;Glycated haemoglobin;GLP-1;Five-Item Lipid Panel;Blood Pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory factor;Complete Blood Count;Three-Item Renal Function Panel;Other Biochemical Tests; | — |
Countries
China
Contacts
Public ContactChen Weijun
Reproductive Hospital Affiliated to Jiangxi University of Traditional Chinese Medicine
Outcome results
None listed