Clinical trial NCT05499585: Treating Pediatric NAFLD with Nutrition
Official title: Treating Pediatric NAFLD with Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Liver Diseases
Liver Fat
Hepatic Steatosis
Nutritional and Metabolic Disease
Keywords: child
adolescent
nutrition
liver
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2022-08-12
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in hepatic steatosis measured by liver MRI-PDFF
timeFrame: Baseline to 12 weeks and 12 weeks to 24 weeks
Secondary outcomes:
measure: Change in serum alanine transaminase (ALT)
timeFrame: Baseline, week 12 and week 24
measure: Change in serum aspartate transaminase (AST)
timeFrame: Baseline, week 12 and week 24
measure: Change in serum gamma-glutamyl transpeptidase (GGT)
timeFrame: Baseline, week 12 and week 24
measure: Change in serum total cholesterol
timeFrame: Baseline, week 12 and week 24
measure: Change in serum LDL-cholesterol
timeFrame: Baseline, week 12 and week 24
measure: Change in serum HDL-cholesterol
timeFrame: Baseline, week 12 and week 24
measure: Change in serum triglycerides
timeFrame: Baseline, week 12 and week 24
measure: Change in plasma fatty acid levels
timeFrame: Baseline, week 12 and week 24
measure: Change in subcutaneous adipose tissue (SCAT)
timeFrame: Baseline, week 12 and week 24
measure: Change in visceral adipose tissue (VAT)
timeFrame: Baseline, week 12 and week 24
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
affiliation: UC San Diego
name: Jeffrey Schwimmer, MD
role: PRINCIPAL_INVESTIGATOR
References: