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A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2% Fat Cows Milk | Placebo Comparator | Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks. |
|
| Standard Soy Milk | Experimental | Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Soy Milk | Drug | Consumption of commercially available soy milk |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in liver disease severity | Change in liver disease severity, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). A relative PDFF change of 30% correlates with histologic improvement in patients with NAFLD and is commonly used in clinical trials. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP]) | 12 weeks | |
| Change in gamma glutamyl-transferase levels (GGT) | 12 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ann Popelar | Contact | (513) 636-8867 | Ann.Popelar@cchmc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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Prospective parallel arm randomized controlled study
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| 2% Fat Cow's Milk |
| Drug |
Consumption of commercially available 2% cow's milk |
|
| Change in alkaline phosphatase (ALP) |
| 12 weeks |
| Change in fasting triglycerides | 12 weeks |
| Change in total cholesterol (TC) | 12 weeks |
| Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels | 12 weeks |
| Change in glucose | 12 weeks |
| Change in insulin | 12 weeks |
| Change in glycated hemoglobin (HbA1c) | 12 weeks |
| Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels | 12 weeks |
| Change in thyroid function (TSH and Free T4) | 12 weeks |
| Change in estradiol | 12 weeks |
| Change in serum metabolome and lipidome | 12 weeks |
| Change in systolic and diastolic blood pressure | 12 weeks |
| Change in equol production status | 12 weeks |