UC San Diego
La Jolla, California, 92037, United States
NCT Number: NCT05499585
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.
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Notify Me10 year–17 year
All sexes
Interventional
Not applicable
La Jolla, California, 92037, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Competing Health Conditions
Intervention
2 1/2 servings of whole dairy per day
Time frame: 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
Time frame: Baseline, week 12 and week 24
ALT will be measured and compared
Time frame: Baseline, week 12 and week 24
AST will be measured and compared
Time frame: Baseline, week 12 and week 24
GGT will be measured and compared
Time frame: Baseline, week 12 and week 24
Serum total cholesterol will be measured and compared
Time frame: Baseline, week 12 and week 24
Serum LDL-cholesterol will be measured and compared
Time frame: Baseline, week 12 and week 24
Serum HDL-cholesterol will be measured and compared
Time frame: Baseline, week 12 and week 24
Serum triglycerides will be measured and compared
Time frame: Baseline, week 12 and week 24
Plasma fatty acid levels will be measured and compared
Time frame: Baseline, week 12 and week 24
SCAT will be measured and compared
Time frame: Baseline, week 12 and week 24
VAT will be measured and compared
University of California, San Diego
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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