Effect of Probiotics or Berberine in Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL.
Non Alcoholic Fatty Liver, Obesity
About this trial
This is an interventional treatment trial for Non Alcoholic Fatty Liver focused on measuring NAFL; obesity; probiotics; berberine; microbiota;
Eligibility Criteria
Inclusion Criteria:
- age 40 to 60 years;
- women ≥1 year since last menstruation;
- body mass index (BMI): 27.0 kg/m2 to 34.9 kg/m2;
- abdominal obesity-related waist circumference > 80 cm (women) and >94 cm (men) (in accordance to International Diabetes Federation);
- stable body weight in the 3 months prior to the trial (permissible deviation is ± 3 kg);
- NAFL - diagnosed based on USG in accordance with PGE-NAFLD recommendation
Exclusion Criteria:
- history of following alternative diets within 3 months before the study;
- history of use of any dietary supplements in the 3 months before the study;
- history of intake of antibiotics, probiotics, prebiotics within 3 months before the study;
- secondary form of obesity, pharmacological treatment for obesity (in the 3 months before the study), history of bariatric surgery;
- another liver diseases: high risk of NASH (assessed on the FIB-4, according to the PGE-NAFLD recommendation), autoimmune hepatitis, hepatitis B and C, toxic hepatitis, cirrhosis, Wilson's disease, hemochromatosis;
- other gastrointestinal disorders, especially: IBD, celiac disease, gastritis and duodenitis, pancreatic disorders, gastrointestinal symptoms suggestive of IBS;
- clinically significant acute inflammatory process (elevated hsCRP);
- abnormal kidney function (GFR <60mL/min/1,73m2);
- T2D;
- dyslipidemia or hypertension - requiring the introduction and/or change of pharmacological treatment in the 6 months before the trial or during intervention;
- pump inhibitors, anticoagulants, drugs causing metabolic alteration, e.g., SFAs (second-generation antipsychotics);
- diseases requiring nutritional requirement and chronic supplementation;
- alcohol (>30g/d for men and >20g/d for women), nicotine or drug abuse;
- mental disorders, including eating disorders;
- cancer, autoimmune diseases;
- any other condition which may influence on final results of the study or pose a risk for subjects health.
Sites / Locations
- 2 Department of Treatment of Obesity, Metabolic Disorders and Clinical Dietetics, Poznań University of Medical Sciences,Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Probiotic
Berberine
Placebo
Probiotics and Berberine
Individuals receive Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily, for 12 weeks. Intervention: Dietary Supplement: Probiotic
Individuals receive Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Berberine
Individuals receive placebo daily, for 3 months. Intervention: Dietary Supplement: Placebo
Individuals receive: Probiotics (9 strains: B. bifidum W23, B. lactis W51, B. lactis W52, L. acidophilus W37, L. brevis W63, L. casei W56, L. salivarius W24, Lactococcus lactis W19, and Lactococcus lactis W58) in dose: 1x109 colony forming units (CFU), daily and Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Probiotic and Berberine