Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585982
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Synbiotics Impact on Insulin and TNF-α in MAFLD a Gut Microbiota Profile Analysis and RCT Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Gut Microbiota Profile Analysis and Randomized Controlled Trials RCT Study of the Effect of Synbiotics on Insulin and TNF-α in Metabolic Dysfunction -Associated Fatty Liver Disease MAFLD
Status:
RECRUITING
Status Verified Date:
2024-09
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:
Primary Objective To analyze the effect of synbiotic supplementation on metabolic profile insulin and TNF-α and gut microbiota changes in patients with Metabolic dysfunction-Associated Fatty Liver Disease MAFLD
Research question Are there any changes in metabolic profile Insulin and TNF-α and gut microbiota changes in MAFLD patients after synbiotic supplementation
Participants will
Treatment group given supplementation and the control group will be given placebo at a dose of 2x1 tablet for 12 weeks
Patients will visit the hospital every 28 days for up to 4 months for control and follow-up supplementation
patients will be given a supplement consumption compliance logbook and a food record logbook used to record food consumption filled in by the patient
Research question Are there any changes in metabolic profile Insulin and TNF-α and gut microbiota changes in MAFLD patients after synbiotic supplementation
Participants will
Treatment group given supplementation and the control group will be given placebo at a dose of 2x1 tablet for 12 weeks
Patients will visit the hospital every 28 days for up to 4 months for control and follow-up supplementation
patients will be given a supplement consumption compliance logbook and a food record logbook used to record food consumption filled in by the patient
Detailed Description:
Non-alcoholic Fatty Liver Disease NAFLD is a common chronic liver disease estimated to affect 25 of the global population NAFLD is defined as the presence of fat in the liver that is not associated with alcohol consumption The researchers proposed a new term Metabolic Dysfunction-Associated Steatotic Liver Disease MASLD which covers a range of liver conditions associated with metabolic dysregulation including obesity and type 2 diabetes MAFLD is a systemic disease with complications such as obesity which is closely related to glucose and lipid metabolism Obesity is associated with comorbidities such as dyslipidaemia hypertension and diabetes
The pathogenesis mechanism of MAFLD is complex and involves several factors such as mitochondrial dysfunction oxidative stress and increased free fatty acids FFA The multi-hit theory explains how lifestyle environmental and genetic factors contribute to the development of MAFLD The gut microbiota also plays an important role in the development of MAFLD through the gut-liver axis where microbiota imbalance can lead to inflammation and liver damage
Research shows the microbiota composition in MAFLD patients is different from healthy people with an increase in Proteobacteria and Actinobacteria and a decrease in butyrate-producing bacteria Interventions with probiotics and prebiotics synbiotics have been shown to reduce liver fibrosis and improve metabolic profiles We are interested in assessing the effects of synbiotics on changes in metabolic biomarkers insulin TNF-α and gut microbiota in MAFLD patients
The pathogenesis mechanism of MAFLD is complex and involves several factors such as mitochondrial dysfunction oxidative stress and increased free fatty acids FFA The multi-hit theory explains how lifestyle environmental and genetic factors contribute to the development of MAFLD The gut microbiota also plays an important role in the development of MAFLD through the gut-liver axis where microbiota imbalance can lead to inflammation and liver damage
Research shows the microbiota composition in MAFLD patients is different from healthy people with an increase in Proteobacteria and Actinobacteria and a decrease in butyrate-producing bacteria Interventions with probiotics and prebiotics synbiotics have been shown to reduce liver fibrosis and improve metabolic profiles We are interested in assessing the effects of synbiotics on changes in metabolic biomarkers insulin TNF-α and gut microbiota in MAFLD patients
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