Univeristy of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Melanie Cree, MD,PhD
PRINCIPAL_INVESTIGATOR
Yesenia Garcia Reyes, MS
CONTACT
NCT Number: NCT05935826
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.
Interested in participating?
Request Info13 year–18 year
All sexes
Interventional
Phase 3
Aurora, Colorado, 80045, United States
Location status: Recruiting
Melanie Cree, MD,PhD
PRINCIPAL_INVESTIGATOR
Yesenia Garcia Reyes, MS
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA
Other names: Essential Amino Acid Supplement (EAA), AMS22392
2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA
Time frame: Baseline and 8 weeks
Change from baseline in presence/severity of hepatic fat fraction will be measured with MRI, and calculated via the Dixon method as the proton density hepatic fat fraction, which ranges from 0-75%.
Time frame: Baseline and 8 weeks
An approximate measure of insulin sensitivity. Less than 1.0 means you are insulin-sensitive which is optimal. Above 1.9 indicates early insulin resistance. Above 2.9 indicates significant insulin resistance.
Time frame: Baseline and 8 weeks
Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation.
Time frame: Baseline and 8 weeks
Target AST levels in children are between 10-35 (U/L). Higher values may indicate liver inflammation.
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Acronym: AMINOS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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