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

NCT03738358 | Completed

• 1 other identifier: 2016-02-015
• Study Type: interventional
• Target: 39
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-alcoholic Fatty Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in ALT and AST

  0 (baseline) and 12 weeks

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

  Screening (baseline) and 12 weeks

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

  0 (baseline), 6 and 12 weeks

• Change in BMI

  0 (baseline), 6 and 12 weeks

• Change in visceral fat and subcutaneous fat levels

  0 week and 12 weeks

Study Arms (2)

Trehalose

EXPERIMENTAL

Dietary Supplement: Trehalose

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Trehalose DIETARY_SUPPLEMENT

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

Trehalose

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Trehalose

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates; Disaccharides; Oligosaccharides; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: June 30, 2016
• Primary Completion: March 20, 2018
• Study Completion: March 20, 2018
• Last Updated: January 30, 2019

Record last verified: 2019-01