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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
First received
Last updated
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
Health authority
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

Study Design


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
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