Amino acids to reduce liver fat in adolescents
Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
This study is testing if a protein supplement can help teenagers with non-alcoholic fatty liver disease reduce liver fat.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 13 Years to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05935826 on ClinicalTrials.gov |
What this trial studies
This study investigates the effect of a protein supplement on reducing hepatic fat in adolescents aged 13-18 diagnosed with non-alcoholic fatty liver disease (NAFLD). Participants will be randomly assigned to receive either the protein supplement or a placebo for two months, followed by an additional ten months where all participants will receive the protein supplement. The study will utilize MRI to measure liver fat content, body composition assessments, and blood tests to evaluate the outcomes. The goal is to determine if the protein supplement can effectively decrease liver fat compared to the placebo group.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 13-18 with a diagnosis of NAFLD and a BMI at or above the 85th percentile.
Not a fit: Patients with diabetes, severe illness, or those on medications affecting insulin sensitivity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new dietary intervention to help reduce liver fat in adolescents with NAFLD.
How similar studies have performed: Other studies have shown promising results with dietary interventions for NAFLD, but this specific approach with amino acids is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Aurora, Colorado
- Univeristy of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Principal investigator: Melanie Cree, MD, PhD — University of Colorado, Denver
- Study coordinator: Yesenia Garcia Reyes, MS
- Email: yesenia.garciareyes@childrenscolorado.org
- Phone: 720-777-6984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.