Fatty Liver Disease
Conditions
Keywords
Metabolic dysfunction-associated fatty liver disease, Gut Microbiota, Metabolic profile, Synbiotic
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.
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. The investigators are interested in assessing the effects of synbiotics on changes in metabolic biomarkers, insulin, TNF-α, and gut microbiota in MAFLD patients.
Interventions
DIETARY_SUPPLEMENTTreatment
RILLUS is a synbiotic produced by Kalbe Farma
DIETARY_SUPPLEMENTControl
Placebo produced by Kalbe Farma
Sponsors
Dr. Kariadi General Hospital Medical Center
PT Kalbe Farma Tbk
Universitas Diponegoro
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Drug coding and group assignment are done by the pharmacy, where the investigator only receives data in the form of sample coding but does not know whether the coded sample received an intervention or control.
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Adult patients aged 25-55 years 2. Patients are willing to become research respondents after filling out informed consent 3. Patients can and are willing to consume supplements orally within a predetermined time 4. Patients are willing to record compliance with taking supplements in a diary that has been provided 5. Patients diagnosed with MAFLD by FibroScan interpreted by a specialist in gastroenterology-hepatology with a CAP score ≥263 dB/m
Exclusion criteria
1. Patients with hepatitis (hepatitis B, hepatitis C, and autoimmune hepatitis) and alcoholic liver disease, cirrhosis of the liver 2. Patients who are pregnant, or breastfeeding or in a programme to become pregnant during participation in this study. 3. Patients with a history of alcohol consumption \>40 g/day. 4. Patients with a history of decompensated disease including ascites, encephalopathy, variceal haemorrhage 5. Patients with Hepatocellular Carcinoma (HCC) 6. Patients with a history of bowel resection or bariatric surgery Patients with chronic inflammatory bowel disease (IBD) 7. Patients with a history of antibiotic use or probiotic/prebiotic/synbiotic consumption in the past 1 month 8. Use of Vitamin E and omega-3 fatty acids 9. Patients who were not hospitalised in the last month and therefore did not have any food restrictions related to their illness.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CRP (C-Reactive Protein) | 3 months | Analyzing C-Reactive Protein (CRP) before and after intervention |
| Complete Hematology | 3 months | Complete Hematology analysis before and after intervention |
| Metabolic Profile | 3 months | Analyzing fasting glucose and HbA1C before and after the intervention |
| Insulin | 3 months | Insulin test results were taken before and after the intervention |
| TNF-alpha | 3 months | TNF-alpha test results were taken before and after the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HCV | 3 months | Anti-HCV test is used as a screening to ensure respondents do not have hepatitis |
| HBsAg (Hepatitis B Surface Antigen) | 3 months | HBsAg test is used as a screening to ensure respondents do not have hepatitis |
| Beta Diversity of Gut Microbioata | 4 months | Calculation of Gut Microbiota's species diversity index using Bray Curtis, where the gene expresion were observed at OTUs level. |
| Alpha Diversity of Gut Microbioata | 4 months | Calculation of Gut Microbiota's species diversity index using Shannon Index, where the gene expresion were observed at OTUs level. |
Countries
Indonesia
Contacts
Primary ContactHery D Purnomo, Dr
Backup ContactAdiyan Pramono, PhD
Outcome results
None listed