Clinical Study of 12-week Trehalose Intake in Patients Wi... | NCT03738358

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

NCT03738358

Sponsor

Samsung Medical Center

Status

Completed

Last Update Posted

Jan 30, 2019Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Non-alcoholic Fatty Liver

Interventions

Trehalose
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2016Actual

Primary Completion Date

Mar 20, 2018Actual

Completion Date

Mar 20, 2018Actual

First Submitted Date

Nov 8, 2018

First Submission Date that Met QC Criteria

Nov 8, 2018

First Posted Date

Nov 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2019

Last Update Posted Date

Jan 30, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Trehalose	Experimental		Dietary Supplement: Trehalose
Placebo	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	0 (baseline) and 12 weeks
Change in homeostatic model assessment-insulin resistance (HOMA-IR)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

ID	Term
D005936	Glucans
D011134	Polysaccharides
D002241	Carbohydrates
D004187	Disaccharides