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

Not Applicable

Completed

• Conditions: Non-alcoholic Fatty Liver
• Interventions: Dietary Supplement: Trehalose; Other: Placebo

• Registration Number: NCT03738358
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-30
• Primary Completion: 2018-03-20
• Study Completion: 2018-03-20
• Study First Submitted: 2018-11-08
• Study First Submitted QC: 2018-11-08
• Study First Posted: 2018-11-13
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-28
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Trehalose	Trehalose	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid	0 (baseline), 6 and 12 weeks	the trend of change in blood
Change in BMI	0 (baseline), 6 and 12 weeks	BMI among subjects is measured by physical examination
Adverse event (AE)	0 week, 6 weeks, and 12 weeks	Symptom and signs in subjects are monitored
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