Recruiting
Phase 2

Soymilk

Sponsor:

Marialena Mouzaki

Code:

NCT06133101

Conditions

Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

Interventions

Standard Soy Milk

2% Fat Cow's Milk

Study Details

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

Study ID

NCT06133101

Start date

Jan 15, 2024

Status verified date

Aug, 2024

Completion date

Jun, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5 - 12

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: 2% Fat Cows Milk

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

experimental: Standard Soy Milk

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

Interventions

Standard Soy Milk

Consumption of commercially available soy milk

2% Fat Cow's Milk

Consumption of commercially available 2% cow's milk

Primary outcome measure

  • Change in liver disease severity [ Time Frame: 12 weeks ]

Central Contacts and Locations

Central contacts

Ann Popelar

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

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Ann Popelar

513-636-8867Ann.Popelar@cchmc.org

Principal Investigator:

Marialena Mouzaki, MD

More Information

Sponsor

Marialena Mouzaki

Last update posted

Aug 20, 2024

Last verified

Aug, 2024

Keywords

  • NAFLD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Marialena Mouzaki on 2024-08-20.