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

Marialena Mouzaki

Status and phase: Enrolling; Phase 2

Conditions: Non-Alcoholic Fatty Liver Disease

Treatments: Drug: 2% Fat Cow's Milk; Drug: Standard Soy Milk

Study type: Interventional

Funder types: Other

Identifiers

NCT06133101

2023-0416

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 5 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups, including a placebo group

2% Fat Cows Milk

Placebo Comparator group

Description:

Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.

Treatment:

Drug: 2% Fat Cow's Milk

Standard Soy Milk

Experimental group

Description:

Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.

Treatment:

Drug: Standard Soy Milk