NCT06133101

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Marialena Mouzaki · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Standard Soy Milk	Consumption of commercially available soy milk
DRUG	2% Fat Cow's Milk	Consumption of commercially available 2% cow's milk

Timeline

• Start date: 2024-01-15
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2023-11-15
• Last updated: 2024-08-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study