Effect of Probiotics or Berberine in Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL.

Effect of Probiotics or Berberine Supplementation on Hepatic Steatosis Markers, Cardiometabolic and Microbiotic Profile in NAFL - A Randomized Double- Blind Clinical Study.

Effect of oral selected Probiotics (PRO) and/or Berberine (BBR) supplementation on hepatic steatosis markers, cardiometabolic profile, and gut microbiota profile in the non-alcoholic fatty liver (NAFL) - a randomized double-blind clinical study.

Probiotics (PRO) and bioactive natural substances such as Berberine (BBR) can improve metabolic parameters in patients with obesity and metabolic disorders. In addition, they significantly affect the composition and function of gut microbiota (GM) and support anti-inflammation and antioxidant defense. These data have become the starting point for the proposed multidirectional approach, aimed at assessing the effect of PRO and/or BBR supplementation on:

• hepatic-related outcomes,
• changes in anthropometric measurements (body mass, BMI, body mass composition and fat mass % content),
• cardiometabolic profile (e.g. blood pressure, noninvasive markers of endothelial function, cardiometabolic biochemical parameters)
• microbiotic profile (gut microbiota composition, endotoxemia)
• the content of the minerals, in overweight/obese patients with nonalcoholic fatty liver (NAFL).

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.