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

Samsung Medical Center39 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Non-alcoholic Fatty Liver

Interventions

TrehaloseDIETARY_SUPPLEMENT

80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g

PlaceboOTHER

80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g

Eligibility

Sex: ALLMin age: 19 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: Screening (baseline) and 12 weeks

Secondary Outcomes

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

Time frame: 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

Time frame: Screening (baseline) and 12 weeks

Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid

the trend of change in blood

Time frame: 0 (baseline), 6 and 12 weeks

Change in BMI

BMI among subjects is measured by physical examination

Time frame: 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.

Time frame: 0 week and 12 weeks

Adverse event (AE)

Symptom and signs in subjects are monitored

Time frame: 0 week, 6 weeks, and 12 weeks

Data from ClinicalTrials.gov

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