A Carbohydrate-restricted Diet to Reverse Fatty Liver in Adolescents With Obesity
Condition: Non-alcoholic Fatty Liver Disease; Childhood Obesity; Insulin Resistance
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity; Insulin Resistance; Pediatric Obesity
Study type: Interventional

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.
    

Intervention name(s): Carbohydrate-restricted diet; Control, low-fat diet
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: childhood obesity; Non-alcoholic fatty liver disease; insulin resistance; carbohydrate-restriction