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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 13
Maximum Age: 18
Healthy Volunteers: f
View:

• Ages 13-18, Tanner stage 4-5

• Suspected or diagnosed with NAFLD per fibroscan or liver biopsy within 6 months prior to enrollment as long as participants have not lost more than 5% of total body weight. Their MRI liver fat \>5.5%

• Diagnosis of non-alcoholic fatty liver disease (NAFLD) per hepatologist

• Sedentary- less than 3 hours of moderate (jogging, swimming, etc.) exercise a week

• BMI equal or greater than the 85th percentile for age and gender, this is overweight and obese categories

Locations
United States
Colorado
Univeristy of Colorado Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Yesenia Garcia Reyes, MS
yesenia.garciareyes@childrenscolorado.org
720-777-6984
Time Frame
Start Date: 2024-06-18
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 55
Treatments
Active_comparator: Amino Acid Supplement
Participants are blindly randomized and for this arm, participants will take the Essential Amino Acid Supplement for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants
Placebo_comparator: Placebo
Participants are blindly randomized and for this arm, participants will take the Placebo for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov