Summary

Eligibility
for people ages 10-17 (full criteria)
Location
at La Jolla, California
Dates
study started
estimated completion
Principal Investigator
by Jeffrey Schwimmer, MD

Description

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.

Details

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, we will measure liver fat (using MRI) at 2 time points separated by 12 weeks to establish the current amount of liver fat. We will then instruct children 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 we will measure liver fat with MR once again. We will also measure labs to assess safety and further evaluate the liver

Keywords

Non-Alcoholic Fatty Liver Disease Liver Diseases Liver Fat Hepatic Steatosis Nutritional and Metabolic Disease child adolescent nutrition liver Fatty Liver Metabolic Diseases

Eligibility

You can join if…

Open to people ages 10-17

  • 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

You CAN'T join if...

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

Location

  • UC San Diego accepting new patients
    La Jolla California 92037 United States

Lead Scientist at UCSD

  • Jeffrey Schwimmer, MD
    Professor Of Clinical, Pediatrics, Vc-health Sciences-schools. Authored (or co-authored) 140 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05499585
Study Type
Interventional
Participants
Expecting 20 study participants
Last Updated