Clinical trial NCT05935826: Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Official title: Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hepatic Steatosis
NAFLD
Adolescent Obesity
Keywords: Amino Acid Supplement
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-07-07
Enrollment: 55
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria

* 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

Exclusion Criteria

* Use of medications known to affect insulin sensitivity: metformin, oral glucocorticoids within 10 days, atypical antipsychotics, immunosuppressant agents, HIV medications.
* Currently pregnant or breastfeeding women. Development of pregnancy during the study period will necessitate withdrawal from the study
* Severe illness requiring hospitalization within 60 days
* Diabetes, defined as Hemoglobin A1C \> 6.4%
* BMI percentile less than the 85th percentile for age and sex. Waist circumference \>200 cm
* Anemia, defined as Hemoglobin \< 11 mg/dL
* Diagnosed major psychiatric or developmental disorder limiting informed consent
* Implanted metal devices that are not compatible with MRI
* Use of blood pressure medications
* Known liver disease other than NAFLD or AST or ALT \>150 IU/L

Primary outcomes:
measure: Change in Hepatic Fat Fraction
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: Baseline and 8 weeks
measure: Change in alanine aminotransferase (ALT)
timeFrame: Baseline and 8 weeks
measure: Change in aspartate aminotransferase (AST)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Univeristy of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Melanie Cree, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: