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

Primary Purpose

Hepatic Steatosis, NAFLD, Adolescent Obesity

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Purity formulation by Amino Co
Placebo
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Steatosis focused on measuring Amino Acid Supplement

Eligibility Criteria

13 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Amino Acid Supplement

    Placebo

    Arm Description

    Treatment

    Placebo

    Outcomes

    Primary Outcome Measures

    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%.

    Secondary Outcome Measures

    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.
    Change in alanine aminotransferase (ALT)
    Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation.
    Change in aspartate aminotransferase (AST)
    Target AST levels in children are between 10-35 (U/L). Higher values may indicate liver inflammation.

    Full Information

    First Posted
    June 28, 2023
    Last Updated
    September 13, 2023
    Sponsor
    University of Colorado, Denver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05935826
    Brief Title
    Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
    Acronym
    AMINOS
    Official Title
    Effect of Amino Acids on Hepatic Fat Content in Adolescents (AMINOS Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    February 2025 (Anticipated)
    Study Completion Date
    June 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatic Steatosis, NAFLD, Adolescent Obesity
    Keywords
    Amino Acid Supplement

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    55 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Amino Acid Supplement
    Arm Type
    Active Comparator
    Arm Description
    Treatment
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Purity formulation by Amino Co
    Intervention Description
    2 months of twice daily consumption of Purity or Placebo
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo powder
    Primary Outcome Measure Information:
    Title
    Change in Hepatic Fat Fraction
    Description
    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 Outcome Measure Information:
    Title
    Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
    Description
    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
    Title
    Change in alanine aminotransferase (ALT)
    Description
    Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation.
    Time Frame
    Baseline and 8 weeks
    Title
    Change in aspartate aminotransferase (AST)
    Description
    Target AST levels in children are between 10-35 (U/L). Higher values may indicate liver inflammation.
    Time Frame
    Baseline and 8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yesenia Garcia Reyes, MS
    Phone
    720-777-6984
    Email
    yesenia.garciareyes@childrenscolorado.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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