Treating Pediatric NAFLD With Nutrition

Sponsor

University of California, San Diego (Other)

Overall Status

Recruiting

CT.gov ID

NCT05499585

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease Liver Diseases Liver Fat Hepatic Steatosis Nutritional and Metabolic Disease	Other: Nutrition	N/A

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, 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Treating Pediatric NAFLD With Nutrition

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: Arm One Habitual diet for 12 weeks followed by experimental diet for 12 weeks	Other: Nutrition 2 1/2 servings of whole dairy per day

Arm

Intervention/Treatment

Other: Arm One

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

Other: Nutrition

2 1/2 servings of whole dairy per day

Outcome Measures

Primary Outcome Measures

Change in hepatic steatosis measured by liver MRI-PDFF [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 Outcome Measures

Change in serum alanine transaminase (ALT) [Baseline, week 12 and week 24]
ALT will be measured and compared
Change in serum aspartate transaminase (AST) [Baseline, week 12 and week 24]
AST will be measured and compared
Change in serum gamma-glutamyl transpeptidase (GGT) [Baseline, week 12 and week 24]
GGT will be measured and compared
Change in serum total cholesterol [Baseline, week 12 and week 24]
Serum total cholesterol will be measured and compared
Change in serum LDL-cholesterol [Baseline, week 12 and week 24]
Serum LDL-cholesterol will be measured and compared
Change in serum HDL-cholesterol [Baseline, week 12 and week 24]
Serum HDL-cholesterol will be measured and compared
Change in serum triglycerides [Baseline, week 12 and week 24]
Serum triglycerides will be measured and compared
Change in plasma fatty acid levels [Baseline, week 12 and week 24]
Plasma fatty acid levels will be measured and compared
Change in subcutaneous adipose tissue (SCAT) [Baseline, week 12 and week 24]
SCAT will be measured and compared
Change in visceral adipose tissue (VAT) [Baseline, week 12 and week 24]
VAT will be measured and compared

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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