Treating Pediatric NAFLD With Nutrition
Primary Purpose
Non-Alcoholic Fatty Liver Disease, Liver Diseases, Liver Fat
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Dairy
Sponsored by
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring child, adolescent, nutrition, liver
Eligibility Criteria
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
Sites / Locations
- UC San DiegoRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm One
Arm Description
Habitual diet for 12 weeks followed by experimental diet for 12 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in serum alanine transaminase (ALT)
ALT will be measured and compared
Change in serum aspartate transaminase (AST)
AST will be measured and compared
Change in serum gamma-glutamyl transpeptidase (GGT)
GGT will be measured and compared
Change in serum total cholesterol
Serum total cholesterol will be measured and compared
Change in serum LDL-cholesterol
Serum LDL-cholesterol will be measured and compared
Change in serum HDL-cholesterol
Serum HDL-cholesterol will be measured and compared
Change in serum triglycerides
Serum triglycerides will be measured and compared
Change in plasma fatty acid levels
Plasma fatty acid levels will be measured and compared
Change in subcutaneous adipose tissue (SCAT)
SCAT will be measured and compared
Change in visceral adipose tissue (VAT)
VAT will be measured and compared
Full Information
NCT ID
NCT05499585
First Posted
August 10, 2022
Last Updated
June 1, 2023
Sponsor
University of California, San Diego
1. Study Identification
Unique Protocol Identification Number
NCT05499585
Brief Title
Treating Pediatric NAFLD With Nutrition
Official Title
Treating Pediatric NAFLD With Nutrition
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease, Liver Diseases, Liver Fat, Hepatic Steatosis, Nutritional and Metabolic Disease
Keywords
child, adolescent, nutrition, liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm One
Arm Type
Other
Arm Description
Habitual diet for 12 weeks followed by experimental diet for 12 weeks
Intervention Type
Other
Intervention Name(s)
Whole Dairy
Intervention Description
2 1/2 servings of whole dairy per day
Primary Outcome Measure Information:
Title
Change in hepatic steatosis measured by liver MRI-PDFF
Description
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 to 12 weeks and 12 weeks to 24 weeks
Secondary Outcome Measure Information:
Title
Change in serum alanine transaminase (ALT)
Description
ALT will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in serum aspartate transaminase (AST)
Description
AST will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in serum gamma-glutamyl transpeptidase (GGT)
Description
GGT will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in serum total cholesterol
Description
Serum total cholesterol will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in serum LDL-cholesterol
Description
Serum LDL-cholesterol will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in serum HDL-cholesterol
Description
Serum HDL-cholesterol will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in serum triglycerides
Description
Serum triglycerides will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in plasma fatty acid levels
Description
Plasma fatty acid levels will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in subcutaneous adipose tissue (SCAT)
Description
SCAT will be measured and compared
Time Frame
Baseline, week 12 and week 24
Title
Change in visceral adipose tissue (VAT)
Description
VAT will be measured and compared
Time Frame
Baseline, week 12 and week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia A Ugalde Nicalo
Phone
619.543.7673
Email
pugaldenicalo@health.ucsd.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Alba, MPH
Phone
619.543.5226
Email
amalba@health.ucsd.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Schwimmer, MD
Organizational Affiliation
UC San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Ugalde Nicalo
Phone
619-543-7673
Email
pugaldenicalo@health.ucsd.edu
12. IPD Sharing Statement
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Treating Pediatric NAFLD With Nutrition
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