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

NCT06133101 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2023-0416
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

NAFLD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])

  12 weeks

• Change in gamma glutamyl-transferase levels (GGT)

  12 weeks

• Change in alkaline phosphatase (ALP)

  12 weeks

• Change in fasting triglycerides

  12 weeks

• Change in total cholesterol (TC)

  12 weeks

Study Arms (2)

2% Fat Cows Milk

PLACEBO COMPARATOR

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

Drug: 2% Fat Cow's Milk

Standard Soy Milk

EXPERIMENTAL

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

Drug: Standard Soy Milk

Interventions

Standard Soy Milk DRUG

Consumption of commercially available soy milk

Standard Soy Milk

2% Fat Cow's Milk DRUG

Consumption of commercially available 2% cow's milk

2% Fat Cows Milk

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Marialena Mouzaki: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Ann Popelar

CONTACT

(513) 636-8867; Ann.Popelar@cchmc.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Division of Gastroenterology, Hepatology and Nutrition

Model Details: Prospective parallel arm randomized controlled study

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 15, 2023
• Study Start: January 15, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

US (1)