Study of Protein Supplements to Reduce Liver Fat in Overweight Adolescents with Fatty Liver Disease

What this Trial Is About

This trial focuses on adolescents aged 13 to 18 who have extra fat stored in their liver, a condition known as non-alcoholic fatty liver disease NAFLD. The study aims to find out if taking a protein supplement twice daily for two months can reduce liver fat compared to a placebo. This research is important because reducing liver fat may improve health in young people with overweight or obesity and NAFLD. Participants are randomly assigned to receive either an essential amino acid protein supplement or a placebo for two months without knowing which one they are taking. After this initial period, all participants are offered the protein supplement for an additional ten months in an open-label extension. During the study, participants will take their assigned supplement twice daily and be monitored regularly. Throughout the trial, participants will undergo MRI scans to measure liver fat, body x-rays to assess body composition, and blood tests. These assessments happen at the start and end of the two-month supplement period. The main outcome measured is the change in liver fat. Researchers will also look at changes in insulin resistance and liver enzymes to understand the supplements effects. The study lasts over a year, including the initial two months and the extended ten-month period.

Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)