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Synbiotics Impact on Insulin and TNF-α in MAFLD: a Gut Microbiota Profile Analysis
Sponsor: Universitas Diponegoro
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.
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)
Key Details
Gender
All
Age Range
25 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-03-04
Completion Date
2025-03-07
Last Updated
2024-11-12
Healthy Volunteers
No
Conditions
Interventions
Treatment
RILLUS is a synbiotic produced by Kalbe Farma
Control
Placebo produced by Kalbe Farma
Locations (1)
RSUP Dr. Kariadi
Semarang, Semarang, Indonesia