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

NAFLD Clinical Trial

— AMINOS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05935826
• Other study ID #: 23-0690
• Secondary ID: R44DK135312
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Yesenia Garcia Reyes, MS
• Phone: 720-777-6984
• Email: yesenia.garciareyes[@]childrenscolorado.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 55
• Est. completion date: June 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria

• Ages 13-18, Tanner stage 4-5
• Biopsy-documented hepatic steatosis (HS) - per the steatosis grade. Grade 1-3 required for inclusion
• 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

Related Conditions & MeSH terms

• Adolescent Obesity
• Fatty Liver
• Hepatic Steatosis
• NAFLD
• Pediatric Obesity

Intervention

Dietary Supplement:
• Purity formulation by Amino Co
2 months of twice daily consumption of Purity or Placebo
• Placebo
Placebo powder

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%.	Baseline and 8 weeks
Secondary	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.	Baseline and 8 weeks
Secondary	Change in alanine aminotransferase (ALT)	Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation.	Baseline and 8 weeks
Secondary	Change in aspartate aminotransferase (AST)	Target AST levels in children are between 10-35 (U/L). Higher values may indicate liver inflammation.	Baseline and 8 weeks