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

Non-alcoholic Fatty Liver Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738358
• Other study ID #: 2016-02-015
• Status: Completed
• Phase: N/A
• Start date: June 30, 2016
• Est. completion date: March 20, 2018

Study information

• Verified date: January 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 20, 2018
• Est. primary completion date: March 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Trehalose
80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid	the trend of change in blood	0 (baseline), 6 and 12 weeks
Secondary	Change in BMI	BMI among subjects is measured by physical examination	0 (baseline), 6 and 12 weeks
Secondary	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
Secondary	Adverse event (AE)	Symptom and signs in subjects are monitored	0 week, 6 weeks, and 12 weeks