Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44DK135312 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
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.
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.
After the 2 month intervention, all participants can continue the study and will all receive the protein supplement for an additional 10-months.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amino Acid Supplement | Active Comparator | Participants are blindly randomized and for this arm, participants will take the Essential Amino Acid Supplement for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants |
|
| Placebo | Placebo Comparator | Participants are blindly randomized and for this arm, participants will take the Placebo for 2-months, followed by an open label extension period of 10-months of Essential Amino Acid for all participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essential Amino Acid Supplement by Amino Co | Drug | 2 months of twice daily consumption of Purity (EAA), followed by 10 months open label extension of EAA |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in alanine aminotransferase (ALT) |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yesenia Garcia Reyes, MS | Contact | 720-777-6984 | yesenia.garciareyes@childrenscolorado.org |
| Name | Affiliation | Role |
|---|---|---|
| Melanie Cree, MD, PhD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009765 | Obesity |
| D050177 | Overweight |
Not provided
Not provided
Not provided
Not provided
Not provided
The participants will be randomized to the protein supplement or placebo for 8 weeks. After the 8-week period, there will be a 10-month open label extension to allow all participants to receive the protein supplement for 10-months.
|
| Placebo | Other | 2 months of twice daily consumption of Placebo, followed by 10 months open label extension of EAA |
|
Target ALT levels in children are between 10-30 (U/L). Higher values may indicate liver inflammation. |
| Baseline and 8 weeks |
| 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 |
| D044343 |
| Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |