Health TrialsbyHealthPanel

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

ConditionsHepatic SteatosisNAFLDAdolescent Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age13-18
SponsorUniversity of Colorado, Denver

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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%

Trial design

Design model

Parallel

Treatments tested in this trial

  • Essential Amino Acid Supplement by Amino Co

    Drug

    2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA

  • Placebo

    Other intervention

    2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA

Treatment groups

55 Participants
are divided into 2 treatment groups
Group A: Amino Acid SupplementActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Hepatic Fat Fraction

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

Secondary outcomes

1

Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

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
2

Change in alanine aminotransferase (ALT)

Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation.

Time frame
Baseline and 8 weeks
3

Change in aspartate aminotransferase (AST)

Target AST levels in children are between 10-35 (U/L). Higher values may indicate liver inflammation.

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Source ClinicalTrials.gov
Apply now