NCT02787668

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 9 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
OTHER	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.

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2016-06-01
• Last updated: 2022-02-21

Locations

1 site across 1 country: United States