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

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

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 Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver
• Intervention / Treatment: Dietary supplement: Trehalose; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 77 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; 80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g
Experimental: Trehalose	Dietary supplement: Trehalose; 80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2016
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): March 20, 2018

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 8, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 2016-02-015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No