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Clinical Trial Summary

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.


Clinical Trial 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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05523024
Study type Interventional
Source Poznan University of Medical Sciences
Contact Malgorzata Moszak, PhD
Phone +48-6185-49-377
Email mmoszak@ump.edu.pl
Status Recruiting
Phase N/A
Start date August 2, 2022
Completion date June 1, 2024

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