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.
Trial summary
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. Read more about this study
- 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
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Nutrition Science Initiative
- Responsible party
- Principal investigator, Jeffrey B. Schwimmer, MD, University of California, San Diego
- Investigators
- Jeffrey B Schwimmer, MD, Principal investigator, University of California, San DiegoMiriam Vos, MD, Principal investigator, Emory University
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 14571229Schwimmer 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 17015527Schwimmer 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 18591439Jin 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 22544914Jin 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 25111123Schwimmer 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 25529941Jin 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 26203597Cohen 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 40812479Cohen 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 34907907Schwimmer 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
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.
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.
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
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.
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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.
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.