Treating Pediatric NAFLD With Nutrition

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Treating Pediatric NAFLD With Nutrition

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05499585
• Other study ID #: 803602
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: University of California, San Diego
• Contact: Patricia A Ugalde Nicalo
• Phone: 619.543.7673
• Email: pugaldenicalo[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Whole Dairy
2 1/2 servings of whole dairy per day

Locations

Country	Name	City	State
United States	UC San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in serum alanine transaminase (ALT)	ALT will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in serum aspartate transaminase (AST)	AST will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in serum gamma-glutamyl transpeptidase (GGT)	GGT will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in serum total cholesterol	Serum total cholesterol will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in serum LDL-cholesterol	Serum LDL-cholesterol will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in serum HDL-cholesterol	Serum HDL-cholesterol will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in serum triglycerides	Serum triglycerides will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in plasma fatty acid levels	Plasma fatty acid levels will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in subcutaneous adipose tissue (SCAT)	SCAT will be measured and compared	Baseline, week 12 and week 24
Secondary	Change in visceral adipose tissue (VAT)	VAT will be measured and compared	Baseline, week 12 and week 24