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

Samsung Medical Center

Status

Completed

Conditions

Non-alcoholic Fatty Liver

Treatments

Other: Placebo

Dietary Supplement: Trehalose

Study type

Interventional

Funder types

Other

Identifiers

NCT03738358

2016-02-015

Details and patient eligibility

About

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.

Enrollment

39 patients

Sex

All

Ages

19 to 79 years old

Volunteers

No Healthy Volunteers

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