Treating Pediatric NAFLD with Nutrition

NCT05499585 | Completed

• 1 other identifier: 803602
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Liver Diseases; Liver Fat; Hepatic Steatosis; Nutritional and Metabolic Disease

Keywords

child; adolescent; nutrition; liver

Outcome Measures

Primary Outcomes (1)

• Change in hepatic steatosis measured by liver MRI-PDFF

  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

  Baseline to 12 weeks and 12 weeks to 24 weeks

Secondary Outcomes (10)

• Change in serum alanine transaminase (ALT)

  Baseline, week 12 and week 24

• Change in serum aspartate transaminase (AST)

  Baseline, week 12 and week 24

• Change in serum gamma-glutamyl transpeptidase (GGT)

  Baseline, week 12 and week 24

• Change in serum total cholesterol

  Baseline, week 12 and week 24

• Change in serum LDL-cholesterol

  Baseline, week 12 and week 24

Study Arms (1)

Arm One

OTHER

Habitual diet for 12 weeks followed by experimental diet for 12 weeks

Other: Whole Dairy

Interventions

Whole Dairy OTHER

2 1/2 servings of whole dairy per day

Arm One

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 may not qualify 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC San Diego

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Liver Diseases; Fatty Liver; Metabolic Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jeffrey Schwimmer, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor of Clinical Pediatrics

Study Record Dates

• First Submitted: August 10, 2022
• First Posted: August 12, 2022
• Study Start: September 12, 2022
• Primary Completion: August 15, 2024
• Study Completion: September 10, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

US (1)