Effects of Berberine in Reducing Abdominal Visceral Adipose Tissue Among Individuals With Obesity and NAFLD (BRAVO)
Obesity, Obesity, Abdominal, NAFLD
About this trial
This is an interventional treatment trial for Obesity focused on measuring berberine hydrochloride
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with established coronary heart disease, stroke, or peripheral arterial disease Patients diagnosed with diabetes or taking oral glucose-lowering drugs Patients 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 hypothyroidism Patients with cardiac insufficiency 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 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 Patients diagnosed with glucose-6-phosphate dehydrogenase (G6PD) deficiency Taking berberine or drug containing berberine in the past 1 month Any adverse reaction to berberine Severe 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 biomarkers Women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial Patients with malignant tumors Patients with mental disorders, cognitive disorders, and/or other serious diseases Those who participated or have been participating other trials during the last 3 months Any other conditions that may hinder the compliance to the study intervention or follow-up visit
Sites / Locations
- Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
berberine group
placebo group
Berberine hydrochloride plus lifestyle intervention
Placebo plus lifestyle intervention