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OpenTrials
Completed

NCT Number: NCT05499585

Treating Pediatric NAFLD with Nutrition

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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Key information

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC San Diego

La Jolla, California, 92037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole Dairy

Other

2 1/2 servings of whole dairy per day

Primary outcomes

  1. Change in hepatic steatosis measured by liver MRI-PDFF

    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

Secondary outcomes

  1. Change in serum alanine transaminase (ALT)

    Time frame: Baseline, week 12 and week 24

    ALT will be measured and compared

  2. Change in serum aspartate transaminase (AST)

    Time frame: Baseline, week 12 and week 24

    AST will be measured and compared

  3. Change in serum gamma-glutamyl transpeptidase (GGT)

    Time frame: Baseline, week 12 and week 24

    GGT will be measured and compared

  4. Change in serum total cholesterol

    Time frame: Baseline, week 12 and week 24

    Serum total cholesterol will be measured and compared

  5. Change in serum LDL-cholesterol

    Time frame: Baseline, week 12 and week 24

    Serum LDL-cholesterol will be measured and compared

  6. Change in serum HDL-cholesterol

    Time frame: Baseline, week 12 and week 24

    Serum HDL-cholesterol will be measured and compared

  7. Change in serum triglycerides

    Time frame: Baseline, week 12 and week 24

    Serum triglycerides will be measured and compared

  8. Change in plasma fatty acid levels

    Time frame: Baseline, week 12 and week 24

    Plasma fatty acid levels will be measured and compared

  9. Change in subcutaneous adipose tissue (SCAT)

    Time frame: Baseline, week 12 and week 24

    SCAT will be measured and compared

  10. Change in visceral adipose tissue (VAT)

    Time frame: Baseline, week 12 and week 24

    VAT will be measured and compared

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 12, 2022
Registry last updated
Sep 26, 2024

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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