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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-03-20

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Trehalose

Group Type EXPERIMENTAL

Trehalose

Intervention Type DIETARY_SUPPLEMENT

80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Trehalose

80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No