Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563921
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
RE and Probiotics in MAFLDNAFLD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
PRObiotic Mixed With Exercise THErapy USe in MAFLD PROMETHEUS in MAFLD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This project aims to evaluate the roles of the autonomic nervous system ANS and gut microbiota as correlates of clinical improvement in metabolic dysfunction-associated fatty liver disease MAFLD and non-alcoholic fatty liver disease NAFLD in response to a therapeutic regimen comprising resistance exercise and probiotic supplementation The primary objective is to investigate the effects of these non-pharmacological interventions on MAFLDNAFLD and to identify patient phenotypes based on baseline ANS profiles and gut microbiota composition that predict clinical responses
Detailed Description:
The human microbiome understood here as the collective community of microorganisms their genetic material and metabolic products that colonize the body from birth is particularly concentrated in the gut The gut microbiome dominated primarily by anaerobic bacteria encompasses thousands of species and millions of genes distributed among the major phyla Firmicutes Bacteroidetes Actinobacteria Proteobacteria and Verrucomicrobia Recent research has increasingly focused on the gut microbiome due to its dysbiosis being linked to numerous diseases that may be modifiable through diet supplementation or physical activity Dysbiosis of the gut microbiome has also been implicated in MAFLD and NAFLD which are the most prevalent liver diseases globally affecting approximately 35 of the adult population with this prevalence expected to rise The gut-liver axis has been extensively studied in relation to MAFLDNAFLD due to the bidirectional interactions between the gut microbiota and hepatic function The portal vein which supplies approximately 70 of the livers blood flow facilitates this interaction by connecting the intestines to the liver Patients with NAFLDMAFLD typically exhibit increased intestinal permeability compared to healthy individuals thereby increasing the livers exposure to gut-derived bacteria endotoxins bacterial products and inflammatory mediators
Probiotics defined as live microorganisms that confer health benefits to the host have been shown in previous studies to enhance the integrity of the intestinal barrier regulate the gut microbiota reduce intestinal permeability and mitigate immune and metabolic disturbances These effects are particularly relevant in patients with NAFLDMAFLD where probiotics have been observed to reduce hepatic steatosis and inflammation-related damage
Physical exercise particularly structured programs has been demonstrated to significantly improve liver function in patients with NAFLDMAFLD and positively modulate the gut microbiota Exercise may attenuate the production of reactive oxygen species ROS and other oxidative agents in NAFLD by regulating antioxidant enzymes and anti-inflammatory mediators Additionally exercise interventions in these patients have been shown to improve blood lipid profiles including triglycerides cholesterol AST and ALT levels offering substantial clinical benefits Although the existing literature predominantly emphasizes aerobic training this study seeks to compare the effects of resistance training and probiotic supplementation in patients with NAFLDMAFLD and to assess potential changes in clinical outcomes Furthermore the study will explore the influence of baseline ANS and gut microbiota profiles on the patients responses to these non-pharmacological therapies
Probiotics defined as live microorganisms that confer health benefits to the host have been shown in previous studies to enhance the integrity of the intestinal barrier regulate the gut microbiota reduce intestinal permeability and mitigate immune and metabolic disturbances These effects are particularly relevant in patients with NAFLDMAFLD where probiotics have been observed to reduce hepatic steatosis and inflammation-related damage
Physical exercise particularly structured programs has been demonstrated to significantly improve liver function in patients with NAFLDMAFLD and positively modulate the gut microbiota Exercise may attenuate the production of reactive oxygen species ROS and other oxidative agents in NAFLD by regulating antioxidant enzymes and anti-inflammatory mediators Additionally exercise interventions in these patients have been shown to improve blood lipid profiles including triglycerides cholesterol AST and ALT levels offering substantial clinical benefits Although the existing literature predominantly emphasizes aerobic training this study seeks to compare the effects of resistance training and probiotic supplementation in patients with NAFLDMAFLD and to assess potential changes in clinical outcomes Furthermore the study will explore the influence of baseline ANS and gut microbiota profiles on the patients responses to these non-pharmacological therapies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None