A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity

Insulin Resistance Clinical Trial

Official title:

A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787668
• Other study ID #: F160218006
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: April 2018

Study information

• Verified date: February 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Fatty Liver
• Insulin Resistance
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity
• Pediatric Obesity

Intervention

Other:
• Carbohydrate-restricted diet
Participants will be randomized (20 per group) to the carbohydrate restricted diet (i.e., CHO <10%; fat >65%, protein 25%) or a low fat diet (CHO 55%; fat 20%; protein 25%) for 8 weeks. Individual counseling with the study physician and registered dietitian (RD) will be provided at baseline for initial assessment and diet instruction. Participants will meet with a RD for an individual counselling session at week 2, 4, and 6 of the diet intervention to ensure adherence to the diet prescription. Participants will be encouraged to keep track of dietary intake by using electronic food diaries (weeks 1-8) to review with the RD during individual counseling at week 2, week 4 and week 6.
• Control, low-fat diet
Individual counseling with the study physician and registered dietitian (RD) will be provided at baseline for initial assessment and diet instruction. Participants will meet with a RD for an individual counselling session at week 2, 4, and 6 of the diet intervention to ensure adherence to the diet prescription. Participants will be encouraged to keep track of dietary intake by using electronic food diaries (weeks 1-8) to review with the RD during individual counseling at week 2, week 4 and week 6.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hepatic lipid assessed via magnetic resonance imaging (MRI and magnetic resonance spectroscopy (MRS).		8 weeks after baseline
Secondary	Change in body composition via dual-energy X-ray absorptiometry (DXA).		8 weeks after baseline
Secondary	Change in liver enzymes via fasting blood draw		At baseline and weeks 2, 4, and 8.
Secondary	Change in fasting glucose via blood draw		At baseline and weeks 2, 4, and 8.
Secondary	Change in fasting insulin via blood draw		At baseline and weeks 2, 4, and 8.