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

Poznan University of Medical Sciences (PUMS)

Status: Enrolling

Conditions: Non Alcoholic Fatty Liver; Obesity

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Probiotc and Berberine; Dietary Supplement: Probiotic; Dietary Supplement: Berberine

Study type: Interventional

Funder types: Other

Identifiers

NCT05523024

491/20 ;

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 140 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups, including a placebo group

Probiotic

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotic

Berberine

Active Comparator group

Description:

Individuals receive Berberine (Berberine hydrochloride 97% extract of Berberis aristata) in dose: 1500 mg/day, for 12 weeks. Intervention: Dietary Supplement: Berberine

Treatment:

Dietary Supplement: Berberine

Placebo

Placebo Comparator group

Description:

Individuals receive placebo daily, for 3 months. Intervention: Dietary Supplement: Placebo

Treatment:

Dietary Supplement: Placebo

Probiotics and Berberine

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotc and Berberine