RSUP Dr. Kariadi
Semarang, 50244, Indonesia
Location status: Recruiting
NCT Number: NCT06585982
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.
Interested in participating?
Request Info25 year–55 year
All sexes
Interventional
Not applicable
Semarang, 50244, Indonesia
Location status: Recruiting
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. The investigators are interested in assessing the effects of synbiotics on changes in metabolic biomarkers, insulin, TNF-α, and gut microbiota in MAFLD patients.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
RILLUS is a synbiotic produced by Kalbe Farma
Placebo produced by Kalbe Farma
Time frame: 3 months
Complete Hematology analysis before and after intervention
Time frame: 3 months
Analyzing fasting glucose and HbA1C before and after the intervention
Time frame: 3 months
Analyzing liver function SGOT (Serum Glutamic Oxaloacetic Transaminase) and SGPT (Serum Glutamic Pyruvic Transaminase) before and after intervention
Time frame: 3 months
Analyzing lipid profile (total cholesterol, triglycerides, HDL, LDL) before and after intervention
Time frame: 3 months
Insulin test results were taken before and after the intervention
Time frame: 3 months
TNF-alpha test results were taken before and after the intervention
Time frame: 3 months
Analyzing C-Reactive Protein (CRP) before and after intervention
Time frame: 4 months
Calculation of Gut Microbiota's species diversity index using Shannon Index, where the gene expresion were observed at OTUs level.
Time frame: 3 months
Anti-HCV test is used as a screening to ensure respondents do not have hepatitis
Time frame: 3 months
HBsAg test is used as a screening to ensure respondents do not have hepatitis
Time frame: 4 months
Calculation of Gut Microbiota's species diversity index using Bray Curtis, where the gene expresion were observed at OTUs level.
Contact information is provided by the study sponsor or research team.
Adiyan Pramono, PhD
CONTACT
Hery D Purnomo, Dr
CONTACT
Universitas Diponegoro
Other
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)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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