Clinical trial NCT02787668: A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity
Official title: A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Childhood Obesity
Insulin Resistance
Keywords: childhood obesity
Non-alcoholic fatty liver disease
insulin resistance
carbohydrate-restriction
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-06-01
Enrollment: 27
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of a low carbohydrate diet vs a low fat diet on improvement in aminotransferases, hepatic fat infiltration, markers of inflammation, insulin resistance, and body composition in obese adolescents with non-alcoholic fatty liver disease (NAFLD).

Detailed description: NAFLD is the most common form of liver disease in children in the United States. Currently, there is no treatment for NAFLD. In adults, weight loss through caloric restriction is commonly recommended to improve fatty liver. Weight loss is particularly difficult for children to achieve and significant caloric restriction may not be a prudent recommendation in developing children and adolescents. Because of this difficulty with weight loss in children, many children go on to develop cirrhosis and eventually undergo liver transplant. Data on the effectiveness of diet to reverse fatty liver and prevent progression to cirrhosis in children is urgently needed. To date, no studies have been done examining how changes in diet composition without intentional caloric restriction influences NAFLD in children. Data from previous studies in adults support the hypothesis that consumption of lower-CHO, higher-fat food sources rich in high-quality proteins and essential fatty acids has beneficial effects on metabolic health in adults without restricting calories. This study aims to test the hypothesis that a low CHO higher- fat diet will induce rapid reversal of fatty liver while also depleting of total and abdominal adiposity, preserving lean mass, and reducing inflammation in adolescents with obesity and NAFLD.

Eligibility criteria: Inclusion Criteria:

* Overweight/obese (BMI over the 85th percentile) male and female adolescents (age range 10-17) with elevated serum aminotransferase levels, diffusely echogenic liver via ultrasound suggestive of fatty liver, and/or prior diagnosis of NAFLD. Participant eligibility will depend on the ability of one parent to attend the initial diet instruction and individual counseling sessions with the registered dietitian during week 2, 4 and 6 of the diet intervention.

Exclusion Criteria:

* Presence of hepatic virus infections (HCV RNA-polymerase chain reaction negative; hepatitis A, B, C, D, E, and G; cytomegalovirus; and Epstein-Barr virus), alcohol consumption, history of parenteral nutrition, and use of drugs known to induce steatosis (for example, valproate, amiodarone, or prednisone) or to affect body weight and carbohydrate metabolism. Autoimmune liver disease, metabolic liver disease, and Wilson's disease will be ruled out by the participants physician prior to enrollment in the study.

Primary outcomes:
measure: Change in hepatic lipid assessed via magnetic resonance imaging (MRI and magnetic resonance spectroscopy (MRS).
timeFrame: 8 weeks after baseline
Secondary outcomes:
measure: Change in body composition via dual-energy X-ray absorptiometry (DXA).
timeFrame: 8 weeks after baseline
measure: Change in liver enzymes via fasting blood draw
timeFrame: At baseline and weeks 2, 4, and 8.
measure: Change in fasting glucose via blood draw
timeFrame: At baseline and weeks 2, 4, and 8.
measure: Change in fasting insulin via blood draw
timeFrame: At baseline and weeks 2, 4, and 8.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Amy M Goss, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dowla S, Pendergrass M, Bolding M, Gower B, Fontaine K, Ashraf A, Soleymani T, Morrison S, Goss A. Effectiveness of a carbohydrate restricted diet to treat non-alcoholic fatty liver disease in adolescents with obesity: Trial design and methodology. Contemp Clin Trials. 2018 May;68:95-101. doi: 10.1016/j.cct.2018.03.014. Epub 2018 Mar 27.