Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06133101
• Other study ID #: 2023-0416
• Status: Recruiting
• Phase: Phase 2
• Start date: January 15, 2024
• Est. completion date: June 2026

Study information

• Verified date: March 2024
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Allison Sullivan
• Phone: 513-803-1065
• Email: allison.sullivan2[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A randomized, controlled study of standard soy milk consumption compared to 2% fat cow's milk consumption in children with Non-alcoholic Fatty Liver Disease (NAFLD). The investigators hypothesize that the daily consumption of soy isoflavones found in the soy milk will be beneficial in reducing NAFLD and other obesity-related comorbidities. The investigators do not expect any adverse endocrine or metabolomic effects from the consumption of soy isoflavones.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: June 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 12 Years

Eligibility

Inclusion Criteria:

• Children with overweight/obesity
• Non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF >10%
• Known NAFLD or elevated ALT for sex (>22 for females and >26 for males)

Exclusion Criteria:

• MRI-PDFF <10%
• Baseline habitual (>3 days per week) consumption of soy foods
• Allergy to soy or cow's milk protein
• Inability to undergo MRI
• Recent (past 8 weeks) antibiotic exposure
• Treatment for existing endocrine disorders

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-Alcoholic Fatty Liver Disease

Intervention

Drug:
• Standard Soy Milk
Consumption of commercially available soy milk
• 2% Fat Cow's Milk
Consumption of commercially available 2% cow's milk

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Marialena Mouzaki

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in liver disease severity	Change in liver disease severity, measured using magnetic resonance imaging-proton density fat fraction (MRI-PDFF). A relative PDFF change of 30% correlates with histologic improvement in patients with NAFLD and is commonly used in clinical trials.	12 weeks
Secondary	Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])		12 weeks
Secondary	Change in gamma glutamyl-transferase levels (GGT)		12 weeks
Secondary	Change in alkaline phosphatase (ALP)		12 weeks
Secondary	Change in fasting triglycerides		12 weeks
Secondary	Change in total cholesterol (TC)		12 weeks
Secondary	Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels		12 weeks
Secondary	Change in glucose		12 weeks
Secondary	Change in insulin		12 weeks
Secondary	Change in glycated hemoglobin (HbA1c)		12 weeks
Secondary	Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels		12 weeks
Secondary	Change in thyroid function (TSH and Free T4)		12 weeks
Secondary	Change in estradiol		12 weeks
Secondary	Change in serum metabolome and lipidome		12 weeks
Secondary	Change in systolic and diastolic blood pressure		12 weeks
Secondary	Change in equol production status		12 weeks