Treating Pediatric NAFLD With Nutrition

Study Overview
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Brief Summary
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This is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD.

Detailed Description
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Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children, estimated to be present in 5-10% of all children in the United States. NAFLD is a growing cause of cirrhosis and liver cancer. There is not yet an FDA approved treatment for NAFLD. Guidelines recommend improvement in diet at the first line of treatment; however, there is no consensus as to what that diet should be. General health guidelines recommend nonfat or low fat dairy over whole dairy after age 2. Limited studies have suggested that whole dairy may be better for people with NAFLD. This study will test the effect of whole dairy on liver fat in children age 10-17 with NAFLD. As a baseline, the investigators will measure liver fat (using MRI) at 2 time points separated by 12 weeks to establish the current amount of liver fat. The children will be instructed to incorporate 2 ½ servings of whole dairy (as milk and/or yogurt provided by the study will provide) into their daily diet. After 12 weeks, the investigators will measure liver fat with MR and labs to assess safety and further evaluate the liver.

Official Title
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Treating Pediatric NAFLD With Nutrition

Conditions
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Non-Alcoholic Fatty Liver Disease, Liver Diseases, Liver Fat, Hepatic Steatosis, Nutritional and Metabolic Disease

Intervention / Treatment
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* Other: Whole Dairy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 10 through 17 years NAFLD ALT of ≥ 40 U/L MRI-PDFF ≥ 8% Ability and willingness of legal guardian and participant to provide written, informed consent Exclusion Criteria: Competing Health Conditions Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigator Type 1 or Type 2 Diabetes LDL-cholesterol > 160 mg/dL Evidence of other chronic liver disease (alcohol liver disease, alcohol related liver disease, hepatitis C, chronic hepatotoxic drug use, mitochondrial diseases, autoimmune liver disease, wilson's disease) History of bariatric surgery or planning to undergo bariatric surgery during the study duration Participant with a history of conditions affecting digestion and/or absorption Intervention Inability or refusal to consume dairy Cow's milk protein allergy Lactose intolerance

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm One<br>Habitual diet for 12 weeks followed by experimental diet for 12 weeks | Other: Whole Dairy<br>* 2 1/2 servings of whole dairy per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hepatic steatosis measured by liver MRI-PDFF | The primary outcome for the 24 week study is to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with NAFLD | Baseline to 12 weeks and 12 weeks to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum alanine transaminase (ALT) | ALT will be measured and compared | Baseline, week 12 and week 24 | 
| Change in serum aspartate transaminase (AST) | AST will be measured and compared | Baseline, week 12 and week 24 | 
| Change in serum gamma-glutamyl transpeptidase (GGT) | GGT will be measured and compared | Baseline, week 12 and week 24 | 
| Change in serum total cholesterol | Serum total cholesterol will be measured and compared | Baseline, week 12 and week 24 | 
| Change in serum LDL-cholesterol | Serum LDL-cholesterol will be measured and compared | Baseline, week 12 and week 24 | 
| Change in serum HDL-cholesterol | Serum HDL-cholesterol will be measured and compared | Baseline, week 12 and week 24 | 
| Change in serum triglycerides | Serum triglycerides will be measured and compared | Baseline, week 12 and week 24 | 
| Change in plasma fatty acid levels | Plasma fatty acid levels will be measured and compared | Baseline, week 12 and week 24 | 
| Change in subcutaneous adipose tissue (SCAT) | SCAT will be measured and compared | Baseline, week 12 and week 24 | 
| Change in visceral adipose tissue (VAT) | VAT will be measured and compared | Baseline, week 12 and week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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child, adolescent, nutrition, liver