This study wants to learn if taking a protein supplement drink twice a day for 8 weeks can help lower the amount of fat that is stored in the liver.
It has been shown that children with higher amounts of fat in their liver are at greater risk for developing other health problems such as type 2 diabetes and cardiovascular disease. We want to try to find the best method for lowering the amount of fat in the liver and improving the lives and health of children. There are two parts to the study. The first part lasts 8 weeks and will compare the effects of a protein supplement drink compared to a placebo drink. The placebo drink looks and tastes the same but does not have protein in it. Your child will be randomly assigned to one of the groups, like flipping a coin. In the second part of the study, everyone will take the protein drink for 10 months. The entire study will last no more than 16 months. During this time your child will come to 5 visits at Children's Hospital Colorado. At the study visits, we will do a physical exam and ask your child to fill out surveys about their daily habits. We will use a needle in their arm to take blood samples. We will also ask them to have body scans (X-rays and MRIs) to see the effects of the supplement drink on the liver and body. You can be paid up to $500 if you complete all parts of the study.
You/your child may be a good fit for this study if they are between 13 and 18 years old and have been diagnosed with fatty liver disease by a doctor. You also need to have a BMI at or above the 85th percentile for your age and currently be doing 3 hours or less of moderate exercise per week. If you are interested in joining this study, a doctor will do other tests to make sure the study is safe and a good fit.
Protocol Number: 23-0690
More information available at ClinicalTrials.gov: NCT05935826