Non-alcoholic Fatty Liver
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTTrehalose
80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g
OTHERPlacebo
80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in liver fat content scanned by CT | Screening (baseline) and 12 weeks | Trehalose group and placebo comparator group are scanned by CT to compare the difference of liver fat content |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in homeostatic model assessment-insulin resistance (HOMA-IR) | Screening (baseline) and 12 weeks | Change from baseline of HOMA-IR, the trend of change in blood, the proportion of subjects with normal HOMA-IR level |
| Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid | 0 (baseline), 6 and 12 weeks | the trend of change in blood |
| Change in ALT and AST | 0 (baseline) and 12 weeks | Change from baseline of ALT and AST, the trend of change in blood, the proportion of subjects with normal ALT and AST level |
| Change in visceral fat and subcutaneous fat levels | 0 week and 12 weeks | Both visceral fat and subcutaneous fat levels are anlayzed by CT scan. |
| Adverse event (AE) | 0 week, 6 weeks, and 12 weeks | Symptom and signs in subjects are monitored |
| Change in BMI | 0 (baseline), 6 and 12 weeks | BMI among subjects is measured by physical examination |
Outcome results
None listed