Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease

Study Overview
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Brief Summary
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This clinical study will be conducted to evaluate the efficacy and safety of trehalose in patients with fatty liver disease. After 12-week intake, subjects will be checked up fat content in liver using CT scan.

Official Title
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A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Trehalose in Patients With Fatty Liver Disease

Conditions
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Non-alcoholic Fatty Liver

Intervention / Treatment
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* Dietary Supplement: Trehalose
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 19-year-old and 79-year-old Weight (≥50kg) Is diagnosed as fatty liver on ultrasonography within 24 weeks from screening day Has willingness and ability to participate whole clinical study period Willing to give informed consent form Exclusion Criteria: Patient with alcoholic fatty liver Patient with inflammatory bowel disease Is required treatment for like liver, kidney, digestive system, circulatory system, respiratory system, endocrine system(except diabetes), musculoskeletal, neuropsychiatry, or hemato-oncology etc., which is able to effect on clinical study Has any medical history with virus or toxic hepatitis Has any medical history of gastrointestinal surgery (except simple appendectomy & repair of hernia) Has medical history of malignant tumor (except non-melanoma skin cancer) within the last 5 years from the screening day Took any drugs (UDCA, silymarin, omega-3, fenofibrate etc.) which is decided as unsuitable drug for combined-dose by investigator Over 4 times of maximum reference range of ALT or AST Average drinking quantity per week > alcohol 140 g Pregnant or nursing women Is currently participating into another clinical study Being made a decision from investigator as unsuitable to participate this study

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trehalose<br> | Dietary Supplement: Trehalose<br>* 80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* 80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in liver fat content scanned by CT | Trehalose group and placebo comparator group are scanned by CT to compare the difference of liver fat content | Screening (baseline) and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ALT and AST | Change from baseline of ALT and AST, the trend of change in blood, the proportion of subjects with normal ALT and AST level | 0 (baseline) and 12 weeks | 
| Change in homeostatic model assessment-insulin resistance (HOMA-IR) | Change from baseline of HOMA-IR, the trend of change in blood, the proportion of subjects with normal HOMA-IR level | Screening (baseline) and 12 weeks | 
| Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid | the trend of change in blood | 0 (baseline), 6 and 12 weeks | 
| Change in BMI | BMI among subjects is measured by physical examination | 0 (baseline), 6 and 12 weeks | 
| Change in visceral fat and subcutaneous fat levels | Both visceral fat and subcutaneous fat levels are anlayzed by CT scan. | 0 week and 12 weeks | 
| Adverse event (AE) | Symptom and signs in subjects are monitored | 0 week, 6 weeks, and 12 weeks |