Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
Participants 13-18 years of age with extra fat stored in the liver will be randomly assigned to a protein supplement or placebo "fake supplement" for 2 months to see if the participants who get the protein supplement have less fat in the liver compared to participants who were in the placebo group. After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
Full description
The goal of this study is to test if taking a protein supplement can help reduce fat that is stored in the liver in children 13-18 years of age with extra fat stored in the liver. The main question it aims to answer is if participants who take the protein supplement for 2 months twice daily have less fat in the liver, when compared to participants who take a placebo or "fake supplement". Participants will be randomly assigned to the protein supplement or placebo and neither study team nor participants will know which group they are assigned to and will have tests done They will have an MRI to measure fat in the liver, a body x-ray to measure body composition and a blood draw when they start and finish their assigned supplement.
After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
55 participants in 2 patient groups, including a placebo group
Loading...
Central trial contact
Yesenia Garcia Reyes, MS
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal