---
title: Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease
nct_id: NCT03738358
overall_status: COMPLETED
phase: NA
sponsor: Samsung Medical Center
study_type: INTERVENTIONAL
primary_condition: Non-alcoholic Fatty Liver
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03738358.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03738358"
ct_last_update_post_date: 2019-01-30
last_seen_at: "2026-05-12T07:31:20.513Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT03738358](https://clinicaltrials.gov/study/NCT03738358)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 39
- **Lead Sponsor:** Samsung Medical Center
- **Conditions:** Non-alcoholic Fatty Liver
- **Start Date:** 2016-06-30
- **Completion Date:** 2018-03-20
- **CT.gov Last Update:** 2019-01-30

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 79 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Trehalose** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## 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
- **Placebo** (OTHER) — 80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g

## Primary Outcomes

- **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

- **Change in ALT and AST** _(time frame: 0 (baseline) and 12 weeks)_
- **Change in homeostatic model assessment-insulin resistance (HOMA-IR)** _(time frame: Screening (baseline) and 12 weeks)_
- **Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid** _(time frame: 0 (baseline), 6 and 12 weeks)_
- **Change in BMI** _(time frame: 0 (baseline), 6 and 12 weeks)_
- **Change in visceral fat and subcutaneous fat levels** _(time frame: 0 week and 12 weeks)_
- **Adverse event (AE)** _(time frame: 0 week, 6 weeks, and 12 weeks)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03738358.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03738358*  
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