None listed
Conditions
Interventions
Others(health functional food) : The test food of this human application test is MCT192C, which is taken orally twice a day, twice a day, twice a day, and once a capsule of test food B with sufficient
Sponsors
MetaCen Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 2) Fatty liver patients with metabolic abnormalities whose liver fibrosis grade was higher than F2 (8.2 kPa) in the Fibroscan examination conducted in Visit 1 3) A person who can maintain the same lifestyle habits (such as diet therapy, exercise therapy, etc.) that he/she has maintained even before participating in the human body application test during the human body application test 4) A person who has agreed to participate in the human body application test before the commencement of the human body application test and has completed a written consent form
Exclusion criteria
Exclusion criteria: 1) Those currently receiving treatment for severe cardiovascular, immune, respiratory, gastrointestinal/liver and biliary systems, kidney and urinary systems, nervous system, endocrine, psychiatric, infectious diseases, and malignant tumors. 2) A person who has a history of alcohol and drug use/abuse, or is hospitalized, receiving medication, or rehabilitation due to central nervous system disorders, etc 3) A person who has a history of liver transplantation or whose liver cancer has been confirmed through abdominal ultrasound 4) A person who has a problem with taking food for human application testing due to gastrointestinal disorders 5) Those with chronic underlying liver disease (hemoglobinosis, hepatocellular carcinoma, autoimmune liver disease, chronic viral hepatitis, etc.) except for metabolic abnormal fatty liver disease 6) A person who has received a new anti-lipid drug and obesity treatment (food inhibitors and fat absorption inhibitors) within 3 months (90 days) as of visit 1 (but can participate and be used in combination if he/she has been taking the drug without any change in dose or medication since 3 months (90 days) before visit 1) 7) A person who has received GLP-1 analogs (such as gastroparesis) within 3 months (90 days) based on visit 1 8) A person who has used the following drugs and treatments within one month (30 days) as of visit 1 ? Drugs that affect liver function (anti-tuberculosis drugs, anticonvulsants, gout treatments, antidepressants, and other drugs likely to cause hepatotoxicity) ? BDD preparations, gallstone solutions, liver protection agents, antidotes, drug-dependent treatments (Antidotes, Detoxifying Agents, Drugs Used in Substance Defendance), Vit B complex (However, liver protection agents and Vit B complex can be participated and used in combination if they are being taken without any change in dose or drug from 3 months before visit 1 (90 days)) ? adrenocortical hormone, sex hormone, immunosuppressant, hormone replacement therapy ? Medicines and health functional foods containing VitE 9) A person who has taken or ingested the following drugs (or foods) within two weeks on the basis of visit 1 ? an antiviral agent ? anticoagulant ? systemic antibiotics ? Probiotics, prebiotics, and lactobacillus products taken continuously (more than 4 days a week) 10) A person who has a weight change of 10% or more within one month (30 days) as of visit 1 11) Current smokers as of Visit 1 12) Chronic drinkers* * Drinking alcohol equivalent to an average of 40 g (280 g/week) per day for men and an average of 20 g/week for women (140 g/week) per day for women 13) A person whose AST (GOT) or ALT (GPT) is more than five times the upper limit of the agency's normal limit 14) Those with a TSH of 0.1 µIU/mL or more or 10 µIU/mL or more 15) A person with an eGFR of less than 60 mL/min/1.73 m2 16) Uncontrolled hypertension patients (measurement criteria for systolic blood pressure greater than 160 mmHg or diastolic blood pressure greater than 100 mmHg, test subjects after stabilizing for 10 minutes) 17) Type 1 diabetic, diabetic ketoacidosis or uncontrolled diabetic patients (HbA1c 9% or more) 18) Those who are pregnant, lactating, or planning to become pregnant during this human application test period 19) Those who have participated in other interventional clinical trials (including human trials) within 3 months of visit 1, or who plan to participate in other interventional clinical trials (including human trials) dur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver fibrosis as measured by Fibroscan | — |
Secondary
| Measure | Time frame |
|---|---|
| hepatic steatosis as measured by Fibroscan;Total Bilirubin;blood lipids(Triglyceride, Total Cholesterol, HDL-cholesterol, LDL-cholesterol);FIB-4 Index, NAFLD Fibrosis Score;Agile 3+ Score;AST, ALT, AST/ALT Ratio;Adverse Event;Clinical laboratory tests (hematology, blood chemistry tests, and urinalysis);Vital signs (blood pressure, pulse) and physical measurements (body weight) | — |
Countries
Korea, Republic of
Contacts
Public ContactWON KIM
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Outcome results
None listed