Dietary Treatment Study of Pediatric NAFLD

Nonalcoholic Fatty Liver Disease Clinical Trial

— DTS  

Official title:

Randomized, Controlled Dietary Treatment Study of Pediatric NAFLD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02513121
• Other study ID #: 2015-4405
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: August 31, 2017

Study information

• Verified date: January 2020
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 31, 2017
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 11 Years to 16 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

• 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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Intervention

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

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of California, San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
University of California, San Diego	Emory University, Nutrition Science Initiative

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Alanine Aminotransferase (ALT) From Baseline to Week 8		Measurements done at baseline and week 8
Secondary	Change in Aspartate Aminotransferase (AST) From Baseline to Week 8		Measurements doen at baseline and week 8
Secondary	Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8		Measurements done at baseline and week 8
Secondary	Change in Insulin From Baseline to Week 8		Measurements done at baseline and week 8
Secondary	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	Measurements done at baseline and week 8
Secondary	Change in Triglycerides From Baseline to Week 8		Measurements done at baseline and week 8