Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals with Obesity and NAFLD

Prior treatment

• Patients who had weight loss surgery, or are currently taking drugs for weight loss, or plan to have weight loss surgery or drugs in the following 6 months
• Taking berberine or drug containing berberine in the past 1 month
• Patients who had to use long-term or intermittent corticosteroids, immunosuppressants, antibiotics, or other drugs that affect inflammatory biomarkers

Other illness

• Patients with established coronary heart disease, stroke, or peripheral arterial disease
• Patients with severely uncontrolled hypertension (i.e., SBP≥180mmHg and/or DBP ≥110mmHg)
• Other causes of fatty liver disease, including alcohol or drug abuse, hepatitis B or C, autoimmune, hepatolenticular degeneration, total parenteral nutrition, inflammatory bowel disease, celiac disease, hypothyroidism, Cushing syndrome, β -lipoprotein deficiency, lipid atrophy diabetes, Mauriac syndrome, etc.
• Patients with thyroid disease, including hyperthyroidism or hypothyroidism
• Patients with cardiac insufficiency
• Severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)
• Patients with malignant tumors
• Patients with mental disorders, cognitive disorders, and/or other serious diseases
• Any other conditions that may hinder the compliance to the study intervention or follow-up visit

Lab values

• Patients diagnosed with diabetes or taking oral glucose-lowering drugs
• ALT or AST ≥ 3 times upper limit of normal, liver cirrhosis or hepatic insufficiency
• Patients with renal insufficiency: estimated glomerular filtration rate (eGFR) \< 60 ml/(min×1.73m2)
• Patients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency

Other

• Excess alcohol consumption (i.e., alcohol ≥ 20 g/day in female or alcohol ≥ 30 g/day in male)
• Any adverse reaction to berberine
• Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial
• Those who participated or have been participating other trials during the last 3 months

• Participants aged ≥18 years
• Participants with obesity (i.e., BMI ≥ 28 kg/m2) and abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male)
• Participants with NAFLD diagnosed by ultrasound, computed tomography or magnetic resonance imaging