Dietary Treatment Study of Pediatric NAFLD

NCT02513121 | Completed Results

• 1 other identifier: 2015-4405
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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. 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

Keywords

NAFLD; Steatohepatitis; Nonalcoholic Steatohepatitis (NASH); Liver; Diet; Pediatric; Adolescent

Outcome Measures

Primary Outcomes (1)

• 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.

  Measurements done at baseline and week 8.

Secondary Outcomes (6)

• Change in Alanine Aminotransferase (ALT) From Baseline to Week 8

  Measurements done at baseline and week 8

• Change in Aspartate Aminotransferase (AST) From Baseline to Week 8

  Measurements doen at baseline and week 8

• Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8

  Measurements done at baseline and week 8

• Change in Insulin From Baseline to Week 8

  Measurements done at baseline and week 8

• Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8

  Measurements done at baseline and week 8

Study Arms (2)

Dietary modification

ACTIVE COMPARATOR

Low free sugar diet

Other: Dietary modification

Observational Arm

NO INTERVENTION

Standard of care

Interventions

Dietary modification OTHER

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

Dietary modification

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of California, San Diego: lead
• Emory University: collaborator
• Nutrition Science Initiative: collaborator

Study Sites (2)

University of California, San Diego

San Diego, California, 92093, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Related Publications (9)

• 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.

  PMID: 14571229 BACKGROUND

• 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.

  PMID: 17015527 BACKGROUND

• 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.

  PMID: 18591439 BACKGROUND

• 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.

  PMID: 22544914 BACKGROUND

• 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.

  PMID: 25111123 BACKGROUND

• 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.

  PMID: 25529941 BACKGROUND

• 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.

  PMID: 26203597 BACKGROUND

• 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.

  PMID: 34907907 DERIVED

• 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.

  PMID: 30667502 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

Diet Therapy

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Jeffrey Schwimmer
• Organization: University of California, San Diego

jschwimmer@ucsd.edu

858-966-8907

Study Officials

• Jeffrey B Schwimmer, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Miriam Vos, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 31, 2015
• Study Start: July 1, 2015
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: January 28, 2020
• Results First Posted: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share

Locations

US (2)