Treating Pediatric NAFLD with Nutrition | NCT05499585

Studies
Treating Pediatric NAFLD with Nutrition

NCT05499585

Sponsor

University of California, San Diego

Status

Completed

Last Update Posted

Sep 26, 2024Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

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

Interventions

Whole Dairy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 12, 2022Actual

Primary Completion Date

Aug 15, 2024Actual

Completion Date

Sep 10, 2024Actual

First Submitted Date

Aug 10, 2022

First Submission Date that Met QC Criteria

Aug 10, 2022

First Posted Date

Aug 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 24, 2024

Last Update Posted Date

Sep 26, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jeffrey B. Schwimmer, MD, Principal Investigator, Professor of Clinical Pediatrics, University of California, San DiegoPrincipal Investigator

Lead Sponsor

University of California, San DiegoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm One	Other	Habitual diet for 12 weeks followed by experimental diet for 12 weeks	Other: Whole Dairy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Whole Dairy	Other	2 1/2 servings of whole dairy per day	Arm One

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Change in serum alanine transaminase (ALT)	ALT will be measured and compared	Baseline, week 12 and week 24
Change in serum aspartate transaminase (AST)	AST will be measured and compared

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Schwimmer, MD	UC San Diego	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UC San Diego		La Jolla	California	92037	United States

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D008107	Liver Diseases
D005234	Fatty Liver
D008659	Metabolic Diseases

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided