NCT05935826 Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
| NCT ID | NCT05935826 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Colorado, Denver |
| Condition | Hepatic Steatosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2024-06-18 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 55 participants in total. It began in 2024-06-18 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Melanie Cree, MD, PhD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT05935826 clinical trial?
This trial is open to participants of all sexes, aged 13 Years or older, up to 18 Years, studying Hepatic Steatosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05935826 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 55 participants.
Is NCT05935826 currently recruiting?
Yes, NCT05935826 is actively recruiting participants. Contact the research team at yesenia.garciareyes@childrenscolorado.org for enrollment information.
Where is the NCT05935826 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT05935826 clinical trial?
NCT05935826 is sponsored by University of Colorado, Denver. The principal investigator is Melanie Cree, MD, PhD at University of Colorado, Denver. The trial plans to enroll 55 participants.