RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-01-15
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06133101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Children with overweight/obesity
  2. * Non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF \>10%
  3. * Known NAFLD or elevated ALT for sex (\>22 for females and \>26 for males)
  1. * MRI-PDFF \<10%
  2. * Baseline habitual (\>3 days per week) consumption of soy foods
  3. * Allergy to soy or cow's milk protein
  4. * Inability to undergo MRI
  5. * Recent (past 8 weeks) antibiotic exposure
  6. * Treatment for existing endocrine disorders

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Marialena Mouzaki

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-15
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-01-15
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • NAFLD

Additional Relevant MeSH Terms

  • Non-Alcoholic Fatty Liver Disease