Nonalcoholic Fatty Liver DiseaseDTSNCT02513121

Dietary Treatment Study of Pediatric NAFLD

A study testing Dietary modification in people with Nonalcoholic Fatty Liver Disease, run by University of California, San Diego at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 11 to 16 years, men only
Conditions the study is for: Nonalcoholic Fatty Liver Disease
What is being tested?: Dietary modification
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesUnited States
Study dates: Jul 2015to 31 Aug 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 11 to 16 years
Men only
No healthy volunteers
Child

Who may be able to join

Boys age 11-16 years inclusive.
Clinical history consistent with NAFLD.
Biopsy-proven NAFLD
MRI measured Liver Proton Density Fat Fraction ≥10%
alanine aminotransferase (ALT) ≥ 45 u/L
No evidence of any other liver disease by clinical history or histological evaluation.
Written informed consent from parent or legal guardian.
Written informed assent from the child or adolescent.

Who cannot join

Exclusions will not be based upon gender, race, or ethnicity. Participants with a current history of the following conditions or any other health issues that make it unsafe for them to participate in the opinion of the Investigators will be excluded from the study:
History of significant alcohol intake (Alcohol Use Disorders Identification Test [AUDIT]) or inability to quantify alcohol consumption
Chronic use (more than 2 consecutive weeks) of medications known to cause hepatic steatosis or steatohepatitis in the past year.
The use of other known hepatotoxins within 120 days of baseline
History of total parenteral nutrition (TPN) use in the year prior to screening
History of bariatric surgery or planning to undergo bariatric surgery during the study duration

Show all 23Show fewer

Significant depression
Non-compensated liver disease with any one of the following hematologic, biochemical, and serological criteria on entry into protocol:
Hemoglobin < 10 g/dL
White blood cell < 3,500 cells/mm
Neutrophil count < 1,500 cells/mm3 of blood
Platelets < 130,000 cells/mm3 of blood
Direct bilirubin > 1.0 mg/dL
Total bilirubin > 3 mg/dL
Albumin < 3.2 g/dL
International normalized ratio (INR) > 1.4
Evidence of other chronic liver disease
Children who are currently enrolled in a clinical trial or who received an investigational study drug or a medication with the intent to treat NAFLD/NASH in the past 60 days
Contraindications to MRI, e.g. metal in the eyes, implanted electronic devices, aneurysm clips, pacemaker, cochlear implants
Unable to have or complete the MRI exam due to body weight exceeding scanner table limit or girth exceeding scanner bore diameter
Subjects who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
Families with > 5 individuals
Failure to give informed consent

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Emory University
Atlanta, Georgia, 30322
University of California, San Diego
San Diego, California, 92093

Other trials in United States

About this study

Official title: Randomized, Controlled Dietary Treatment Study of Pediatric NAFLD

This is an investigator initiated study being conducted in equal numbers at two sites, University of California, San Diego (UC San Diego) and Emory University (EU). The purpose of this study is to understand the potential of a low sugar diet for the treatment of nonalcoholic fatty liver disease (NAFLD) in children. Forty boys with NAFLD will be randomly assigned to either an intervention group or a habitual diet control group. The intervention will be a low sugar diet for a period of 8 weeks. The effect of this dietary change will be assessed using advanced magnetic resonance imaging (MRI) testing to measure liver fat.

Conditions: Nonalcoholic Fatty Liver Disease
Being tested: Dietary modification
Keywords: NAFLD, Steatohepatitis, Nonalcoholic Steatohepatitis (NASH), Liver, Diet, Pediatric, Adolescent
Medical subject headings: Non-alcoholic Fatty Liver Disease, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Dietary modificationOther
The intervention is a modification of the family's habitual diet with a low sugar version of their diet.

Study groups in NCT02513121
Study group	Role	What they receive
Dietary modification	Active comparator	Low free sugar diet Receives: Other: Dietary modification
Observational Arm	No intervention	Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (<3%) in boys with NAFLD will change liver fat % measured by MRI.
Measured: Measurements done at baseline and week 8.

Secondary outcomes (6)

Change in Alanine Aminotransferase (ALT) From Baseline to Week 8
Measured: Measurements done at baseline and week 8
Change in Aspartate Aminotransferase (AST) From Baseline to Week 8
Measured: Measurements doen at baseline and week 8
Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8
Measured: Measurements done at baseline and week 8
Change in Insulin From Baseline to Week 8
Measured: Measurements done at baseline and week 8
Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8
HOMA-IR was calculated as follows: fasting insulin (µU/mL) x fasting glucose (nmol/L)/22.5
Measured: Measurements done at baseline and week 8
Change in Triglycerides From Baseline to Week 8
Measured: Measurements done at baseline and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 201531 Aug 2017

First posted31 Jul 2015 (estimated)
Study startJul 2015
Primary completion31 Aug 2017
Study completion31 Aug 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Nonalcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
More trials run by University of California, San DiegoThe 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: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02513121
Sponsor's protocol ID: 2015-4405
Acronym: DTS
Status last verified: Jan 2020
First submitted: 29 Jul 2015
Last updated: 28 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: De-identified participant data will be made available in response to bona fide and good faith, ad hoc requests. Suitability of each request, if consistent with Institutional Review Board (IRB) approval, will be determined only in the case of a favorable vote of a majority of a committee consisting of each consortium investigator and the Grantor. Data will be made available with a signed access agreement.

Publications

Schwimmer JB, Deutsch R, Rauch JB, Behling C, Newbury R, Lavine JE. Obesity, insulin resistance, and other clinicopathological correlates of pediatric nonalcoholic fatty liver disease. J Pediatr. 2003 Oct;143(4):500-5. doi: 10.1067/S0022-3476(03)00325-1.
PubMed 14571229
Schwimmer JB, Deutsch R, Kahen T, Lavine JE, Stanley C, Behling C. Prevalence of fatty liver in children and adolescents. Pediatrics. 2006 Oct;118(4):1388-93. doi: 10.1542/peds.2006-1212.
PubMed 17015527
Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular risk factors and the metabolic syndrome in pediatric nonalcoholic fatty liver disease. Circulation. 2008 Jul 15;118(3):277-83. doi: 10.1161/CIRCULATIONAHA.107.739920. Epub 2008 Jun 30.
PubMed 18591439
Jin R, Le NA, Liu S, Farkas Epperson M, Ziegler TR, Welsh JA, Jones DP, McClain CJ, Vos MB. Children with NAFLD are more sensitive to the adverse metabolic effects of fructose beverages than children without NAFLD. J Clin Endocrinol Metab. 2012 Jul;97(7):E1088-98. doi: 10.1210/jc.2012-1370. Epub 2012 Apr 27.
PubMed 22544914
Jin R, Welsh JA, Le NA, Holzberg J, Sharma P, Martin DR, Vos MB. Dietary fructose reduction improves markers of cardiovascular disease risk in Hispanic-American adolescents with NAFLD. Nutrients. 2014 Aug 8;6(8):3187-201. doi: 10.3390/nu6083187.
PubMed 25111123
Schwimmer JB, Middleton MS, Behling C, Newton KP, Awai HI, Paiz MN, Lam J, Hooker JC, Hamilton G, Fontanesi J, Sirlin CB. Magnetic resonance imaging and liver histology as biomarkers of hepatic steatosis in children with nonalcoholic fatty liver disease. Hepatology. 2015 Jun;61(6):1887-95. doi: 10.1002/hep.27666. Epub 2015 Feb 5.
PubMed 25529941
Jin R, Vos MB. Fructose and liver function--is this behind nonalcoholic liver disease? Curr Opin Clin Nutr Metab Care. 2015 Sep;18(5):490-5. doi: 10.1097/MCO.0000000000000203.
PubMed 26203597
Cohen CC, Dabelea D, Davy BM, Glueck DH, Newton KP, Perng W, Welsh JA, Schwimmer JB, Vos MB. Responsiveness of the Serum Carbon Isotope Ratio to Dietary Added Sugar Reduction in a Randomized Controlled Trial among Youth with Steatotic Liver Disease. J Nutr. 2025 Oct;155(10):3496-3505. doi: 10.1016/j.tjnut.2025.08.006. Epub 2025 Aug 12.
PubMed 40812479
Cohen CC, Li KW, Alazraki AL, Beysen C, Carrier CA, Cleeton RL, Dandan M, Figueroa J, Knight-Scott J, Knott CJ, Newton KP, Nyangau EM, Sirlin CB, Ugalde-Nicalo PA, Welsh JA, Hellerstein MK, Schwimmer JB, Vos MB. Dietary sugar restriction reduces hepatic de novo lipogenesis in adolescent boys with fatty liver disease. J Clin Invest. 2021 Dec 15;131(24):e150996. doi: 10.1172/JCI150996.
PubMed 34907907
Schwimmer JB, Ugalde-Nicalo P, Welsh JA, Angeles JE, Cordero M, Harlow KE, Alazraki A, Durelle J, Knight-Scott J, Newton KP, Cleeton R, Knott C, Konomi J, Middleton MS, Travers C, Sirlin CB, Hernandez A, Sekkarie A, McCracken C, Vos MB. Effect of a Low Free Sugar Diet vs Usual Diet on Nonalcoholic Fatty Liver Disease in Adolescent Boys: A Randomized Clinical Trial. JAMA. 2019 Jan 22;321(3):256-265. doi: 10.1001/jama.2018.20579.
PubMed 30667502

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

All Nonalcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled Dietary Treatment Study of Pediatric NAFLD
ClinicalTrials.gov ID: NCT02513121
Acronym / sponsor ID: DTS / 2015-4405
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: NAFLD, Steatohepatitis, Nonalcoholic Steatohepatitis (NASH), Liver, Diet, Pediatric, Adolescent
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University of California, San DiegoUniversity, hospital or other
Collaborators: Emory University, Nutrition Science Initiative
Study start: Jul 2015
Primary completion: 31 Aug 2017 (actual)
Study completion: 31 Aug 2017 (actual)
First posted: 31 Jul 2015 (estimated)
Results: Posted 28 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Dietary modification	Active comparator	Other: Dietary modificationLow free sugar diet
Observational Arm	No intervention	–Standard of care

Who may qualify

Ages: 11 to 16 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Boys age 11-16 years inclusive.
Clinical history consistent with NAFLD.
Biopsy-proven NAFLD
MRI measured Liver Proton Density Fat Fraction ≥10%
alanine aminotransferase (ALT) ≥ 45 u/L

Key exclusion criteria (23 listed)

Exclusions will not be based upon gender, race, or ethnicity. Participants with a current history of the following conditions or any other health issues that make it unsafe for them to participate in the opinion of the Investigators will be excluded from the study:
History of significant alcohol intake (Alcohol Use Disorders Identification Test [AUDIT]) or inability to quantify alcohol consumption
Chronic use (more than 2 consecutive weeks) of medications known to cause hepatic steatosis or steatohepatitis in the past year.
The use of other known hepatotoxins within 120 days of baseline
History of total parenteral nutrition (TPN) use in the year prior to screening

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
Dietary modificationThe intervention is a modification of the family's habitual diet with a low sugar version of their diet.	Other	Dietary modification

Primary outcome

Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
Time frame: Measurements done at baseline and week 8.
The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (<3%) in boys with NAFLD will change liver fat % measured by MRI.

6 secondary outcomes

Change in Alanine Aminotransferase (ALT) From Baseline to Week 8
Time frame: Measurements done at baseline and week 8
Change in Aspartate Aminotransferase (AST) From Baseline to Week 8
Time frame: Measurements doen at baseline and week 8
Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8
Time frame: Measurements done at baseline and week 8
Change in Insulin From Baseline to Week 8
Time frame: Measurements done at baseline and week 8
Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8
Time frame: Measurements done at baseline and week 8
Change in Triglycerides From Baseline to Week 8
Time frame: Measurements done at baseline and week 8

Results and safety

Results posted to the registry on 28 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Group	20	20
Control Group	20	20

Primary outcome: Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group

Time frame: Measurements done at baseline and week 8.. Mean (95% Confidence Interval). Unit: Percentage of liver fat

Measure	Intervention Group n = 20	Control Group n = 20
Baseline	22.9 (18.7 to 28.0)	19.4 (16.2 to 23.2)
Week 8	14.9 (11.4 to 19.6)	18.0 (14.0 to 22.4)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event details were collected throughout the duration of study participation, from the Baseline visit through the Week 8 follow up visit.. Other adverse events reported at 2.5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intervention Group	0 of 20 (0%)	2 of 20 (10%)	0 of 20
Control Group	0 of 20 (0%)	1 of 20 (5%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 14571229Schwimmer JB, Deutsch R, Rauch JB, Behling C, Newbury R, Lavine JE. Obesity, insulin resistance, and other clinicopathological correlates of pediatric nonalcoholic fatty liver disease. J Pediatr. 2003 Oct;143(4):500-5. doi: 10.1067/S0022-3476(03)00325-1.
Background: PubMed 17015527Schwimmer JB, Deutsch R, Kahen T, Lavine JE, Stanley C, Behling C. Prevalence of fatty liver in children and adolescents. Pediatrics. 2006 Oct;118(4):1388-93. doi: 10.1542/peds.2006-1212.
Background: PubMed 18591439Schwimmer JB, Pardee PE, Lavine JE, Blumkin AK, Cook S. Cardiovascular risk factors and the metabolic syndrome in pediatric nonalcoholic fatty liver disease. Circulation. 2008 Jul 15;118(3):277-83. doi: 10.1161/CIRCULATIONAHA.107.739920. Epub 2008 Jun 30.
Background: PubMed 22544914Jin R, Le NA, Liu S, Farkas Epperson M, Ziegler TR, Welsh JA, Jones DP, McClain CJ, Vos MB. Children with NAFLD are more sensitive to the adverse metabolic effects of fructose beverages than children without NAFLD. J Clin Endocrinol Metab. 2012 Jul;97(7):E1088-98. doi: 10.1210/jc.2012-1370. Epub 2012 Apr 27.
Background: PubMed 25111123Jin R, Welsh JA, Le NA, Holzberg J, Sharma P, Martin DR, Vos MB. Dietary fructose reduction improves markers of cardiovascular disease risk in Hispanic-American adolescents with NAFLD. Nutrients. 2014 Aug 8;6(8):3187-201. doi: 10.3390/nu6083187.
Background: PubMed 25529941Schwimmer JB, Middleton MS, Behling C, Newton KP, Awai HI, Paiz MN, Lam J, Hooker JC, Hamilton G, Fontanesi J, Sirlin CB. Magnetic resonance imaging and liver histology as biomarkers of hepatic steatosis in children with nonalcoholic fatty liver disease. Hepatology. 2015 Jun;61(6):1887-95. doi: 10.1002/hep.27666. Epub 2015 Feb 5.
Background: PubMed 26203597Jin R, Vos MB. Fructose and liver function--is this behind nonalcoholic liver disease? Curr Opin Clin Nutr Metab Care. 2015 Sep;18(5):490-5. doi: 10.1097/MCO.0000000000000203.
Derived from this study: PubMed 40812479Cohen CC, Dabelea D, Davy BM, Glueck DH, Newton KP, Perng W, Welsh JA, Schwimmer JB, Vos MB. Responsiveness of the Serum Carbon Isotope Ratio to Dietary Added Sugar Reduction in a Randomized Controlled Trial among Youth with Steatotic Liver Disease. J Nutr. 2025 Oct;155(10):3496-3505. doi: 10.1016/j.tjnut.2025.08.006. Epub 2025 Aug 12.
Derived from this study: PubMed 34907907Cohen CC, Li KW, Alazraki AL, Beysen C, Carrier CA, Cleeton RL, Dandan M, Figueroa J, Knight-Scott J, Knott CJ, Newton KP, Nyangau EM, Sirlin CB, Ugalde-Nicalo PA, Welsh JA, Hellerstein MK, Schwimmer JB, Vos MB. Dietary sugar restriction reduces hepatic de novo lipogenesis in adolescent boys with fatty liver disease. J Clin Invest. 2021 Dec 15;131(24):e150996. doi: 10.1172/JCI150996.
Derived from this study: PubMed 30667502Schwimmer JB, Ugalde-Nicalo P, Welsh JA, Angeles JE, Cordero M, Harlow KE, Alazraki A, Durelle J, Knight-Scott J, Newton KP, Cleeton R, Knott C, Konomi J, Middleton MS, Travers C, Sirlin CB, Hernandez A, Sekkarie A, McCracken C, Vos MB. Effect of a Low Free Sugar Diet vs Usual Diet on Nonalcoholic Fatty Liver Disease in Adolescent Boys: A Randomized Clinical Trial. JAMA. 2019 Jan 22;321(3):256-265. doi: 10.1001/jama.2018.20579.
Individual participant dataSharing planned: Yes. De-identified participant data will be made available in response to bona fide and good faith, ad hoc requests. Suitability of each request, if consistent with Institutional Review Board (IRB) approval, will be determined only in the case of a favorable vote of a majority of a committee consisting of each consortium investigator and the Grantor. Data will be made available with a signed access agreement.

Related trials for Nonalcoholic Fatty Liver Disease

Active, not recruitingPhase 3
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NASH - Nonalcoholic Steatohepatitis
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Roflumilast in the Treatment of Nonalcoholic Fatty Liver Disease Patients
NAFLD (Nonalcoholic Fatty Liver Disease)
Not yet recruitingPhase 2/3
Evaluating the Safety and Efficacy of Rupatadine in the Treatment of Nonalcoholic Fatty Liver Disease Patients.
NAFLD (Nonalcoholic Fatty Liver Disease)
Recruiting
iWAIST Trial: ERCG (Endoscopic Radial Compression Gastroplasty) +Optimized Lifestyle Intervention (OLI) vs Sham + OLI for Weight Loss
Overweight and/or Obesity, Metabolic Syndrome
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis

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.

Jeffrey B Schwimmer, MD principal investigator

University of California, San Diego

Miriam Vos, MD principal investigator

Emory University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Dietary modification in people with Nonalcoholic Fatty Liver Disease, run by University of California, San Diego at 2 sites in United States.

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 8 inclusion and 23 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 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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?

Yes. Results are posted in the registry (first posted 28 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group (time frame: Measurements done at baseline and week 8.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02513121, which also lists 10 linked publications.

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 28 Jan 2020; AzTrials last refreshed its copy on 6 Nov 2026.