Non-alcoholic Fatty LiverNCT03738358
Clinical Study of 12-week Trehalose Intake in Patients With Fatty Liver Disease
A study testing Trehalose in people with Non-alcoholic Fatty Liver, run by Samsung Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Non-alcoholic Fatty Liver
- What is being tested?
- Trehalose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2016to 20 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
About this study
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
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
- Being tested
- Trehalose, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrehaloseDietary supplement
80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g
PlaceboOther
80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g
| Study group | Role | What they receive |
|---|---|---|
| Trehalose | Experimental | Not described Receives: Dietary Supplement: Trehalose |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Screening (baseline) and 12 weeks
Secondary outcomes (6)
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
Measured: 0 (baseline) and 12 weeks
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
Measured: Screening (baseline) and 12 weeks
Change in total cholesterol, LDL, HDL, triglyceride (TG) and free fatty acid
the trend of change in blood
Measured: 0 (baseline), 6 and 12 weeks
Change in BMI
BMI among subjects is measured by physical examination
Measured: 0 (baseline), 6 and 12 weeks
Change in visceral fat and subcutaneous fat levels
Both visceral fat and subcutaneous fat levels are anlayzed by CT scan.
Measured: 0 week and 12 weeks
Adverse event (AE)
Symptom and signs in subjects are monitored
Measured: 0 week, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2018
- Study start30 Jun 2016
- Primary completion20 Mar 2018
- Study completion20 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty LiverStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung-Ryul Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03738358
- Sponsor's protocol ID
- 2016-02-015
- Status last verified
- Jan 2019
- First submitted
- 8 Nov 2018
- Last updated
- 30 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03738358
- Acronym / sponsor ID
- 2016-02-015
- Conditions
- Non-alcoholic Fatty Liver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 30 Jun 2016 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 20 Mar 2018 (actual)
- First posted
- 13 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trehalose | Experimental | Dietary Supplement: Trehalose |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trehalose80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g | Dietary supplement | Trehalose |
| Placebo80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g | Other | Placebo |
Primary outcome
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
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Trehalose in people with Non-alcoholic Fatty Liver, run by Samsung Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver fat content scanned by CT (time frame: Screening (baseline) and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.