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

This multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine in reducing visceral and liver adipose tissue among individuals with obesity and non-alcoholic fatty liver disease (NAFLD) in China.

Inclusion Criteria:Participants aged ≥18 yearsParticipants 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 imagingExclusion Criteria:Patients with established coronary heart disease, stroke, or peripheral arterial diseasePatients diagnosed with diabetes or taking oral glucose-lowering drugsPatients with severely uncontrolled hypertension (i.e., SBP≥180mmHg and/or DBP ≥110mmHg)Excess alcohol consumption (i.e., alcohol ≥ 20 g/day in female or alcohol ≥ 30 g/day in male)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 hypothyroidismPatients with cardiac insufficiencyALT or AST ≥ 3 times upper limit of normal, liver cirrhosis or hepatic insufficiencyPatients with renal insufficiency: estimated glomerular filtration rate (eGFR) < 60 ml/(min×1.73m2)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 monthsPatients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiencyTaking berberine or drug containing berberine in the past 1 monthAny adverse reaction to berberineSevere constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, Crohn's disease, irritable bowel syndrome, etc.)Patients who had to use long-term or intermittent corticosteroids, immunosuppressants, antibiotics, or other drugs that affect inflammatory biomarkersWomen who are pregnant or breastfeeding, or those who plan to be pregnant during the trialPatients with malignant tumorsPatients with mental disorders, cognitive disorders, and/or other serious diseasesThose who participated or have been participating other trials during the last 3 monthsAny other conditions that may hinder the compliance to the study intervention or follow-up visit