Hepatic Steatosis, Liver Diseases, Liver Fat, Non-Alcoholic Fatty Liver Disease, Nutritional and Metabolic Disease
Conditions
Keywords
child, adolescent, nutrition, liver
Brief summary
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
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.
Interventions
OTHERWhole Dairy
2 1/2 servings of whole dairy per day
Sponsors
University of California, San Diego
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hepatic steatosis measured by liver MRI-PDFF | Baseline to 12 weeks and 12 weeks to 24 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in subcutaneous adipose tissue (SCAT) | Baseline, week 12 and week 24 | SCAT will be measured and compared |
| Change in serum alanine transaminase (ALT) | Baseline, week 12 and week 24 | ALT will be measured and compared |
| Change in serum aspartate transaminase (AST) | Baseline, week 12 and week 24 | AST will be measured and compared |
| Change in serum gamma-glutamyl transpeptidase (GGT) | Baseline, week 12 and week 24 | GGT will be measured and compared |
| Change in visceral adipose tissue (VAT) | Baseline, week 12 and week 24 | VAT will be measured and compared |
| Change in serum LDL-cholesterol | Baseline, week 12 and week 24 | Serum LDL-cholesterol will be measured and compared |
| Change in serum HDL-cholesterol | Baseline, week 12 and week 24 | Serum HDL-cholesterol will be measured and compared |
| Change in serum triglycerides | Baseline, week 12 and week 24 | Serum triglycerides will be measured and compared |
| Change in plasma fatty acid levels | Baseline, week 12 and week 24 | Plasma fatty acid levels will be measured and compared |
| Change in serum total cholesterol | Baseline, week 12 and week 24 | Serum total cholesterol will be measured and compared |
Countries
United States
Outcome results
None listed