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

Primary Purpose

Non-alcoholic Fatty Liver

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Trehalose
Placebo
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Trehalose

    Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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
    Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid
    the trend of change in blood
    Change in BMI
    BMI among subjects is measured by physical examination
    Change in visceral fat and subcutaneous fat levels
    Both visceral fat and subcutaneous fat levels are anlayzed by CT scan.
    Adverse event (AE)
    Symptom and signs in subjects are monitored

    Full Information

    First Posted
    November 8, 2018
    Last Updated
    January 28, 2019
    Sponsor
    Samsung Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03738358
    Brief Title
    Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    June 30, 2016 (Actual)
    Primary Completion Date
    March 20, 2018 (Actual)
    Study Completion Date
    March 20, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Samsung Medical Center

    4. Oversight

    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

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-alcoholic Fatty Liver

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    39 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Trehalose
    Arm Type
    Experimental
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Trehalose
    Intervention Description
    80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g
    Intervention Type
    Other
    Intervention Name(s)
    Placebo
    Intervention Description
    80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g
    Primary Outcome Measure Information:
    Title
    Change in liver fat content scanned by CT
    Description
    Trehalose group and placebo comparator group are scanned by CT to compare the difference of liver fat content
    Time Frame
    Screening (baseline) and 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change in ALT and AST
    Description
    Change from baseline of ALT and AST, the trend of change in blood, the proportion of subjects with normal ALT and AST level
    Time Frame
    0 (baseline) and 12 weeks
    Title
    Change in homeostatic model assessment-insulin resistance (HOMA-IR)
    Description
    Change from baseline of HOMA-IR, the trend of change in blood, the proportion of subjects with normal HOMA-IR level
    Time Frame
    Screening (baseline) and 12 weeks
    Title
    Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid
    Description
    the trend of change in blood
    Time Frame
    0 (baseline), 6 and 12 weeks
    Title
    Change in BMI
    Description
    BMI among subjects is measured by physical examination
    Time Frame
    0 (baseline), 6 and 12 weeks
    Title
    Change in visceral fat and subcutaneous fat levels
    Description
    Both visceral fat and subcutaneous fat levels are anlayzed by CT scan.
    Time Frame
    0 week and 12 weeks
    Title
    Adverse event (AE)
    Description
    Symptom and signs in subjects are monitored
    Time Frame
    0 week, 6 weeks, and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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