Obesity
Conditions
Interventions
Healthy baseline control group:None
Control group:Standard care with placebo
Treatment group:Standard care plus Akkermansia muciniphila AKK PROBIO (10 billion TFU)
Sponsors
The Second Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age 40-60 years. 2.Diagnosis of primary obesity, meeting all the following criteria:BMI between 28.0 and 34.9 kg/m².Waist circumference >= 90 cm. 3.Presence of dyslipidemia or abnormal glucose metabolism (meeting at least one of the following criteria):Total Cholesterol (TC) >= 5.2 mmol/L (subject to adjustment per local laboratory reference ranges), orTriglycerides (TG) >= 1.7 mmol/L (subject to adjustment per local laboratory reference ranges), orLow-Density Lipoprotein Cholesterol (LDL-C) >= 3.4 mmol/L (subject to adjustment per local laboratory reference ranges), orFasting plasma glucose >= 6.1 mmol/L, orGlycated hemoglobin (HbA1c) >= 5.7% (subject to adjustment per local laboratory reference ranges). 4.No use of medications known to affect body weight or lipid profile (e.g., weight-loss drugs, statins, corticosteroids, thiazide diuretics) within the past 3 months. 5.If taking stable doses of non-lipid-lowering and non-weight-loss medications (e.g., antihypertensives, glucose-lowering agents), the specific drug names and dosages must be clearly documented. 6.Provide signed informed consent, voluntarily participate in the study, and commit to adhering to the intervention protocol. 7.Have maintained stable dietary and exercise habits for the past 3 months and be willing to comply with the dietary and exercise guidance provided during the study.
Exclusion criteria
Exclusion criteria: 1.Secondary obesity (e.g., due to hypothyroidism or Cushing's syndrome). 2.Severe hepatic or renal insufficiency (ALT/AST > 3 times the upper limit of normal, Cr > 1.5 times the upper limit of normal). 3.Comorbid severe cardiovascular or cerebrovascular diseases (e.g., acute myocardial infarction, stroke). 4.Gastrointestinal diseases (e.g., inflammatory bowel disease, peptic ulcer). 5.Allergic predisposition or known allergy to probiotics or any component of the Akkermansia muciniphila AKK PROBIO bacterial preparation. 6.Use of antibiotics or probiotic preparations (excluding yogurt) within the past 2 months. 7.Inability to comply with scheduled follow-up visits (poor adherence). 8.Patients with severe obesity (BMI >= 35.0 kg/m^2). 9.Use of medications with potential impact on gut microbiota (e.g., statins, hormones, antibiotics) within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Body mass index;Waist circumference;Skeletal muscle;Basal metabolic rate;Skinfold thickness;Resting systolic blood pressure;Resting heart rate;Fasting Blood Glucose;Postprandial Blood Glucose;Glycosylated Hemoglobin, Type A1C;C-Peptide;Insulin Autoantibodies;Resting Metabolic Rate;Total energy expenditure;White blood cell count;Red blood cell count;Haemoglobin;Platelet count;Hematocrit;Neutrophil count;Lymphocyte count;Absolute Eosinophil Count;Basophil count;Monocyte count;Neutrophil Percentage;Lymphocyte Percentage;Basophil Percentage;Eosinophil Percentage;Monocyte Percentage;Mean corpuscular volume;Mean corpuscular hemoglobin;Mean Corpuscular Hemoglobin Concentration;Red blood cell distribution width;Plateletcrit;Mean platelet volume;PH value;Specific Gravity Of Urine;Proteinuria;Glycosuria;urobilinogen;Bilirubin;Ketone Bodies;Urinary Red Blood;Total cholesterol;Triglyceride;High-Density Lipoprotein Cholesterol;Low-Density Lipoprotein Cholesterol;Total Protein;Globulin;Albumin;Glutamic-oxal (o)acetic transaminase;Alanine transaminase;Total bilirubin;Direct Bilirubin;Cholinesterase;Urea;Serum Creatinine;Uric acid;Apolipoprotein A1;Reactive oxygen species; | — |
Secondary
| Measure | Time frame |
|---|---|
| ATP level;Apolipoprotein B; | — |
Countries
China
Contacts
Public ContactZheng Yingbin
The Second Affiliated Hospital of Zhengzhou University
Outcome results
None listed