Non Alcoholic Fatty Liver Disease
Conditions
Keywords
Non Alcoholic Fatty Liver, Probiotics, Gut-Liver Axis
Brief summary
A study for evaluating the safety and efficacy of L. lactis CKDB001 on liver aminotransferases in subjects with nonalcoholic fatty liver disease
Interventions
DIETARY_SUPPLEMENTProbiotics (L. lactis CKDB001)
L. lactis CKDB001: Enteric coated capsule with L. lactis CKDB001, daily, 12 weeks
DIETARY_SUPPLEMENTPlacebo
Placebo: Enteric coated capsule without any probiotics, daily, 12 weeks
Sponsors
Chuncheon Sacred Heart Hospital
Chong Kun Dang Bio
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adult men and women aged 19 to 75 years at the time of written consent * Voluntarily provided written consent after receiving sufficient explanation about the study * ALT or AST levels exceed the upper limit of normal, but are five times or less than the upper limit
Exclusion criteria
* Pregnant or breastfeeding women * Women of childbearing potential and men who are unable or unwilling to use appropriate contraception during the study period * Individuals with a history of alcohol abuse or chronic alcohol consumption: Daily alcohol consumption averaging over 30g/day (210g/week) for men or over 20g/day (140g/week) for women * Individuals with viral or other liver diseases that could affect study results: * Individuals with a history of or current drug abuse * Individuals with a history of psychiatric disorders or current psychiatric conditions that may interfere with the study * Individuals with a history of major gastrointestinal surgery (excluding appendectomy, but including gastric resection, gastrointestinal bypass, anastomosis, bariatric metabolic surgeries) * Individuals with severe comorbidities that make them unsuitable for study participation (e.g., heart disease, kidney disease, malignancy, immunosuppression, etc.): * Regular consumption of probiotics, prebiotics, synbiotics, or fermented milk within 4 weeks prior to screening (participation allowed if consumption ceases at least 1 month before study start) * Regular consumption of medications, health supplements, or herbal remedies that may affect liver function or anti-inflammatory responses within 4 weeks prior to screening (participation allowed if consumption ceases at least 1 month before study start) * Use of medications that may cause hepatic steatosis (e.g., amiodarone, tamoxifen, methotrexate, tetracycline, corticosteroids) * Use of medications for treating non-alcoholic fatty liver disease (NAFLD) or steatohepatitis (NASH) within 3 months prior to screening (e.g., thiazolidinediones, vitamin E) * Use of medications that may affect study results (e.g., antipyretic analgesics, NSAIDs, anti-tuberculosis drugs, antibiotics, anticonvulsants, choleretics, liver disease medications) * Use of oral steroids, hormones, or drugs that may affect absorption, metabolism, or excretion of food within 4 weeks prior to screening (participation allowed if taking systemic steroids or thyroid hormones in stable doses for ≥3 months before screening) * Use of hypoglycemic agents or lipid-lowering drugs (except insulin or thiazolidinediones) with stable doses for at least 3 months prior to screening * Dietary or exercise therapies that may affect study within 3 months prior to screening * Smokers consuming more than 20 cigarettes per day * Allergies or digestive issues related to study food ingredients * Weight loss exceeding 10% of previous body weight within 6 months prior to screening * Participation in another clinical trial within 30 days prior to screening or not completing the required five-half-life period of investigational drug/food from a previous trial * Any other individuals deemed unsuitable for the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in liver function parameters: AST (U/L), ALT (U/L) | From baseline to 12 weeks | Change from baseline to 12 weeks in the specified liver function parameters will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in liver function parameters: γ-GTP (U/L), ALP (U/L) | From baseline to 12 weeks | Change from baseline to 12 weeks in the specified liver function parameters will be assessed. |
| Changes in bilirubin parameters: Total bilirubin (mg/dL), Direct bilirubin (mg/dL) | From baseline to 12 weeks | Change from baseline to 12 weeks in the specified bilirubin parameters will be assessed. |
| Changes in protein parameters: Total protein (g/dL), Albumin (g/dL), Globulin (g/dL) | From baseline to 12 weeks | Change from baseline to 12 weeks in the specified protein parameters will be assessed. |
| Changes in lipid parameters: Total cholesterol (mg/dL), LDL-C (mg/dL), HDL-C (mg/dL), Triglycerides (mg/dL) | From baseline to 12 weeks | Change from baseline to 12 weeks in the specified lipid parameters will be assessed. |
| Changes in fasting plasma glucose levels (mg/dL) | From baseline to 12 weeks | Change from baseline to 12 weeks in fasting plasma glucose levels will be assessed. |
| Changes in fasting serum insulin levels (μU/mL) | From baseline to 12 weeks | Change from baseline to 12 weeks in fasting serum insulin levels will be assessed. |
| Changes in insulin resistance index: HOMA-IR | From baseline to 12 weeks | Change from baseline to 12 weeks in the insulin resistance index (HOMA-IR) will be assessed. |
| Changes in inflammatory markers: TNF-α (pg/mL), IL-6 (pg/mL), IL-10 (pg/mL) | From baseline to 12 weeks | Change from baseline to 12 weeks in the specified inflammatory cytokine markers will be assessed. |
| Changes in high-sensitivity C-reactive protein levels (mg/L) | From baseline to 12 weeks | Change from baseline to 12 weeks in high-sensitivity C-reactive protein levels will be assessed. |
| Changes in Fatigue Severity Scale (FSS) | From baseline to 12 weeks | Change from baseline to 12 weeks in Fatigue Severity Scale (FSS) score will be assessed. The FSS is a validated 9-item questionnaire with total scores ranging from 9 to 63, where higher scores indicate greater fatigue severity. |
| Changes in gut environment assessed by metagenomics and metabolomics | From baseline to 12 weeks | Change from baseline to 12 weeks in gut environment will be assessed using metagenomic and metabolomic analyses. |
| Changes in body weight (kg) | From baseline to 12 weeks | Change from baseline to 12 weeks in body weight will be assessed. |
| Changes in body mass index (kg/m²) | From baseline to 12 weeks | Change from baseline to 12 weeks in body mass index will be assessed. |
| Changes in waist circumference (cm) | From baseline to 12 weeks | Change from baseline to 12 weeks in waist circumference will be assessed. |
| Changes in hip circumference (cm) | From baseline to 12 weeks | Change from baseline to 12 weeks in hip circumference will be assessed. |
| Changes in waist-to-hip ratio (WHR) | From baseline to 12 weeks | Change from baseline to 12 weeks in waist-to-hip ratio will be assessed. |
Countries
South Korea
Outcome results
None listed