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

Sponsor

Marialena Mouzaki (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06133101

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-Alcoholic Fatty Liver Disease	Drug: Standard Soy Milk Drug: 2% Fat Cow's Milk	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective parallel arm randomized controlled studyProspective parallel arm randomized controlled study

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 2% Fat Cows Milk Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.	Drug: 2% Fat Cow's Milk Consumption of commercially available 2% cow's milk
Experimental: Standard Soy Milk Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.	Drug: Standard Soy Milk Consumption of commercially available soy milk

Arm

Intervention/Treatment

Placebo Comparator: 2% Fat Cows Milk

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

Drug: 2% Fat Cow's Milk

Consumption of commercially available 2% cow's milk

Experimental: Standard Soy Milk

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

Drug: Standard Soy Milk

Consumption of commercially available soy milk

Outcome Measures

Primary Outcome Measures

Change in liver disease severity [12 weeks]
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.

Secondary Outcome Measures

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]
Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels [12 weeks]
Change in glucose [12 weeks]
Change in insulin [12 weeks]
Change in glycated hemoglobin (HbA1c) [12 weeks]
Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels [12 weeks]
Change in thyroid function (TSH and Free T4) [12 weeks]
Change in estradiol [12 weeks]
Change in serum metabolome and lipidome [12 weeks]
Change in systolic and diastolic blood pressure [12 weeks]
Change in equol production status [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 12 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Marialena Mouzaki

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Marialena Mouzaki, Professor, Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital Medical Center, Cincinnati

ClinicalTrials.gov Identifier:

NCT06133101

Other Study ID Numbers:

2023-0416

First Posted:

Nov 15, 2023

Last Update Posted:

Nov 15, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Marialena Mouzaki, Professor, Division of Gastroenterology, Hepatology and Nutrition, Children's Hospital Medical Center, Cincinnati

NAFLD

Additional relevant MeSH terms:

Liver Diseases

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Nov 15, 2023