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Completed

NCT Number: NCT03738358

Clinical Study of 12-week Trehalose Intake 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.

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Key information

Conditions

Non-alcoholic Fatty Liver Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

19 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trehalose

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. Change in liver fat content scanned by CT

    Time frame: Screening (baseline) and 12 weeks

    Trehalose group and placebo comparator group are scanned by CT to compare the difference of liver fat content

Secondary outcomes

  1. Change in ALT and AST

    Time frame: 0 (baseline) and 12 weeks

    Change from baseline of ALT and AST, the trend of change in blood, the proportion of subjects with normal ALT and AST level

  2. Change in homeostatic model assessment-insulin resistance (HOMA-IR)

    Time frame: Screening (baseline) and 12 weeks

    Change from baseline of HOMA-IR, the trend of change in blood, the proportion of subjects with normal HOMA-IR level

  3. Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid

    Time frame: 0 (baseline), 6 and 12 weeks

    the trend of change in blood

  4. Change in BMI

    Time frame: 0 (baseline), 6 and 12 weeks

    BMI among subjects is measured by physical examination

  5. Change in visceral fat and subcutaneous fat levels

    Time frame: 0 week and 12 weeks

    Both visceral fat and subcutaneous fat levels are anlayzed by CT scan.

  6. Adverse event (AE)

    Time frame: 0 week, 6 weeks, and 12 weeks

    Symptom and signs in subjects are monitored

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 13, 2018
Registry last updated
Jan 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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