An interventional study of Placebo and Probiotics in Non-Alcoholic Fatty Liver Disease, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by GenMont Biotech Incorporation · Not applicable, Interventional, and Supportive care
In this study, the improvement of the clinical status of early-stage non-alcoholic fatty liver disease (NAFLD) patients after the probiotic intervention will be assessed. And the mechanism of probiotics to prevent the progression of illness would be investigated. The chronic inflammation status, systemic oxidative stress, metabolism of carbohydrates and lipid, and gut microbiota of NAFLD patients will also be analyzed.
Uncontrolled NAFLD evolves in Non-Alcoholic SteatoHepatitis (NASH), cirrhosis and liver cancer. Early intervention to prevent the progression of illness of NAFLD is very important. From 2005 to 2018, 15 clinical trials concluded that multiple-strain probiotics significantly reduced the liver inflammation index and blood lipids in NAFLD patients. Many reports indicated that NAFLD-associated risk factors, such as chronic inflammation, oxidative stress, insulin resistance, dyslipidemia, and obesity are closely correlated with gut microbiota. Some substances (such as endotoxin and alcohol) produced by harmful gut bacteria caused the progression of the illness of NAFLD.
Three strains are Genmont® Normal Lactobacillus (GMNL) which were divided from natural environments, included Lactobacillus reuteri GMNL-263 (heat-killed) and GMNL-89 (alive) and Lactobacillus rhamnosus GMNL-74 ( alive). They are all isolated from the gastrointestinal tract of healthy Taiwanese and were known as common food material worldwide. The previous clinical research on probiotic consumption in type 2 Diabetes mellitus patients under normal drug treatment was conducted in Changhua Christian Hospital. Results showed that L. reuteri GMNL-263 was able to stabilize the weight and blood pressure of patients. L. reuteri GMNL-89 had a stable effect on glycated hemoglobin. There was no adverse reaction when probiotics combining with type 2 diabetes drugs. Meanwhile, L. rhamnosus GMNL-74 was observed to reduce weight gain in obese mice. In this clinical study, The anti-liver inflammation effect of consumption of Lactobacillus sachet in NAFLD patients will be demonstrated at baseline, 3 months and 6 months. In this clinical study, the anti-liver inflammation effect of consumption of Lactobacillus sachet in NAFLD patients will be demonstrated at baseline, 3 months and 6 months to understand the impact of the probiotics on NAFLD. Since the treatment of fatty liver should focus on controlling weight, blood sugar, and blood fat, the relevant clinical indexes will also be investigated.
Exclusion Criteria:
Subjects received two placebo sachets per day
Other: Placebo
Subjects received two probiotic sachets per day
Dietary Supplement: Probiotics
Same Additives to Probiotic group but replace probiotics with Corn starch and Maltodextrin.
Also known as: Control group
Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-263 (heat-killed) and GMNL-89 (alive) and Lactobacillus rhamnosus GMNL-74 ( alive).
Also known as: Test group
Serum ALT (Alanine Aminotransferase) level at baseline
The number of patients will be enrolled with the concentration of ALT (Alanine Aminotransferase) ranging from 60 to 300 U/mL in serum.
Time frame: baseline
Change from baseline in Serum ALT (Alanine Aminotransferase) level at 3-months
Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).
Time frame: 3-months
Change from baseline in Serum ALT (Alanine Aminotransferase) level at 6-months
Fasting blood samples will be collected to examine the variation of ALT (Alanine Aminotransferase).
Time frame: 6-months
Change from baseline in BMI (Body Mass index) at 3-months
BMI will be calculated with weight and height combined in kg/m\^2, the weight will be measured in kilograms and the height will be recorded in centimeters.
Time frame: 3-months
Change from baseline in BMI (Body Mass index) at 6-months
BMI will be calculated with weight and height combined in kg/m\^2, the weight will be measured in kilograms and the height will be recorded in centimeters.
Time frame: 6-months
Change from baseline in Waist and hip circumference at 3-months
Waist and hip circumference will take down in centimeters.
Time frame: 3-months
Change from baseline in Waist and hip circumference at 6-months
Waist and hip circumference will take down in centimeters.
Time frame: 6-months
Change from baseline in blood pressure at 3-months
The unit of measurement of blood pressure is mmHg. Both systolic and diastolic blood pressure will be measured.
Time frame: 3-months
Change from baseline in blood pressure at 6-months
The unit of measurement of blood pressure is mmHg. Both systolic and diastolic blood pressure will be measured.
Time frame: 6-months
Change from baseline in the progress of the non-alcoholic fatty liver disease at 3-months
Utilizing abdominal ultrasound to detect the progress of Non-alcoholic fatty liver disease (NAFLD).
Time frame: 3-months
Change from baseline in the progress of the non-alcoholic fatty liver disease at 6-months
Utilizing abdominal ultrasound to detect the progress of Non-alcoholic fatty liver disease (NAFLD).
Time frame: 6-months
Change from baseline in levels of AST(Aspartate Aminotransferase) at 3-months
Fasting blood samples will be collected to examine changes from baseline in AST(Aspartate Aminotransferase) in IU/L at 3-months.
Time frame: 3-months
Change from baseline in levels of AST(Aspartate Aminotransferase) at 6-months
Fasting blood samples will be collected to examine changes from baseline in AST(Aspartate Aminotransferase) in IU/L at 6-months.
Time frame: 6-months
Change from baseline in the level of γ-GT (γ-Glutamyl Transpeptidase) at 3-months
Fasting blood samples will be collected to examine changes from baseline in γ-GT (γ-Glutamyl Transpeptidase) in IU/L at 3-months.
Time frame: 3-months
Change from baseline in the level of γ-GT (γ-Glutamyl Transpeptidase) at 6-months
Fasting blood samples will be collected to examine changes from baseline in γ-GT (γ-Glutamyl Transpeptidase) in IU/L at 6-months.
Time frame: 6-months
Change from baseline in the level of BUN (Blood Urea Nitrogen) at 3-months
Fasting blood samples will be collected to examine changes in BUN(Blood Urea Nitrogen) from baseline in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in the level of BUN (Blood Urea Nitrogen) at 6-months
Fasting blood samples will be collected to examine changes from baseline in BUN(Blood Urea Nitrogen) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in the level of CRE (Creatinine) at 3-months
Fasting blood samples will be collected to examine changes from baseline in CRE(Creatinine) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in the level of CRE (Creatinine) at 6-months
Fasting blood samples will be collected to examine changes from baseline in CRE(Creatinine) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in levels of FBS (Fasting Blood Sugar) at 3-months
Fasting blood samples will be collected to examine changes from baseline in FBS(Fasting Blood Sugar) in mg/dL at 6-months.
Time frame: 3-months
Change from baseline in the level of FBS (Fasting Blood Sugar) at 6-months
Fasting blood samples will be collected to examine changes from baseline in FBS(Fasting Blood Sugar) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in levels of HbA1c (Hemoglobin A1C) at 3-months
Fasting blood samples will be collected to investigate the levels of HbA1c(Hemoglobin A1C) in % from baseline at 3-months.
Time frame: 3-months
Change from baseline in levels of HbA1c (Hemoglobin A1C) at 6-months
Fasting blood samples will be collected to investigate the levels of HbA1c(Hemoglobin A1C) in % from baseline at 6-months.
Time frame: 6-months
Change from baseline in levels of serum insulin at baseline
Fasting blood samples will be collected to examine variation in serum insulin in uIU/mL from baseline at 3-months.
Time frame: 3-months
Change from 3-months in levels of serum insulin at baseline
Fasting blood samples will be collected to examine variation in serum insulin in uIU/mL from baseline at 6-months.
Time frame: 6-months
Change from Baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 3-months
HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) will be calculated with insulin and glucose. (HOMA-IR=(insulin (mIU/L) and glucose (mg/dl))/405)
Time frame: 3-months
Change from baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 6-months
HOMA-IR(Homeostatic Model Assessment for Insulin Resistance) will be calculated with insulin and glucose. (HOMA-IR=(insulin (mIU/L) and glucose (mg/dl))/405)
Time frame: 6-months
Change from baseline in levels of TC (Total Cholesterol) at 3-months
Fasting blood samples will be collected to examine variation from baseline in (Total Cholesterol) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in levels of TC (Total Cholesterol) at 6-months
Fasting blood samples will be collected to examine variation from baseline in (Total Cholesterol) in mg/dL from baseline at 6-months.
Time frame: 6-months
Change from baseline in level of HDL (High density lipoprotein) at 3-months
Fasting blood samples will be collected to examine variation from baseline in HDL(High density lipoprotein) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in level of HDL (High density lipoprotein) at 6-months
Fasting blood samples will be collected to examine variation from baseline in HDL(High density lipoprotein) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in level of LDL (Low density lipoprotein) at 3-months
Fasting blood samples will be collected to examine variation from baseline in LDL(Low density lipoprotein) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in level of LDL (Low density lipoprotein) at 6-months
Fasting blood samples will be collected to examine variation from baseline in LDL(Low density lipoprotein) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in level of TG (Triglyceride) at 3-months
Fasting blood samples will be collected to examine variation from baseline in TG(Triglyceride) in mg/dL to 3-months.
Time frame: 3-months
Change from baseline in level of TG (Triglyceride) at 6-months
Fasting blood samples will be collected to examine variation from baseline in TG(Triglyceride) in mg/dL to 6-months.
Time frame: 6-months
Change from baseline in level of hs-CRP (high-sensitivity C-reactive protein) at 3-months
Blood samples will be collected to examine variation from baseline in hs-CRP(high-sensitivity C-reactive protein) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in level of hs-CRP (high-sensitivity C-reactive protein) at 6-months
Blood samples will be collected to examine variation from baseline in hs-CRP(high-sensitivity C-reactive protein) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in level of TNF-α (Tumor necrosis factor-α) at 3-months
Blood samples will be collected to examine variation from baseline in TNF-α (Tumor necrosis factor-α) in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of TNF-α (Tumor necrosis factor-α) at 6-months
Blood samples will be collected to examine variation from baseline in TNF-α (Tumor necrosis factor-α) in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in level of IL-1β (Interleukin-1 β) at 3-months
Blood samples will be collected to examine variation from baseline in IL-1β(Interleukin-1 β) in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of IL-1β (Interleukin-1 β) at 6-months
Blood samples will be collected to examine variation from baseline in IL-1β(Interleukin-1 β) in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in level of IL-6 (Interleukin-6) at 3-months
Blood samples will be collected to examine variation from baseline in IL-6(Interleukin-6) in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of IL-6 (Interleukin-6) at 6-months
Blood samples will be collected to examine variation from baseline in IL-6(Interleukin-6) in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in level of LPS (Lipopolysaccharides) at 3-months
Blood samples will be collected to examine variation from baseline in LPS(Lipopolysaccharides) in mg/dL at 3-months.
Time frame: 3-months
Change from baseline in level of LPS (Lipopolysaccharides) at 6-months
Blood samples will be collected to examine variation from baseline in LPS(Lipopolysaccharides) in mg/dL at 6-months.
Time frame: 6-months
Change from baseline in level of Leptin at 3-months
Blood samples will be collected to examine variation from baseline in Leptin in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of Leptin at 6-months
Blood samples will be collected to examine variation from baseline in Leptin in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in level of Adiponectin at 3-months
Blood samples will be collected to examine variation from baseline in Adiponectin in pg/mL at 3-months.
Time frame: 3-months
Change from baseline in level of Adiponectin at 6-months
Blood samples will be collected to examine variation from baseline in Adiponectin in pg/mL at 6-months.
Time frame: 6-months
Change from baseline in the level of SCFA (Short Chain Fatty Acids) at 6-months
Blood samples will be collected to examine variation from baseline in SCFA (Short Chain Fatty Acids) in ug/mL at 6-months.
Time frame: 6-months
Change from baseline in the level of TMAO (Trimethylamine N-oxide) at 6-months
Blood samples will be collected to examine variation from baseline in TMAO (Trimethylamine N-oxide) in μmol/L at 6-months.
Time frame: 6-months
Change from baseline in Self-questionnaire of Diet and lifestyle assessments at 6-months
The questionnaire will record dietary/drink preferences and other habits by the subject himself /herself, the content of the questionnaire includes vegetarian or not, the frequency if intake of tea, dairy, coffee or yakult intake, smoking habits, betel nuts intake and alcohol consumption.
Time frame: 6-months
Change from baseline in self-record of the International physical activity questionary (IPAQ) in physical assessment at 6-months
The questionnaire will be finished to record the laborious activity by the subject himself /herself before and after the treatment.
Time frame: 6-months
Change from baseline in gut microbiota at 6-months
The analysis of Gut microbiota will utilize DNA sequencing to investigate the intestinal microbiota through stool samples in subjects with NAFLD at 6-months.
Time frame: 6-months
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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GenMont Biotech Incorporation