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NCT Number: NCT06133101

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location status: Recruiting

Location contact

Ann Popelar

CONTACT

[email protected]

513-636-8867

Marialena Mouzaki, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Soy Milk

Drug

Consumption of commercially available soy milk

2% Fat Cow's Milk

Drug

Consumption of commercially available 2% cow's milk

Primary outcomes

  1. Change in liver disease severity

    Time frame: 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 outcomes

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

    Time frame: 12 weeks

  2. Change in gamma glutamyl-transferase levels (GGT)

    Time frame: 12 weeks

  3. Change in alkaline phosphatase (ALP)

    Time frame: 12 weeks

  4. Change in fasting triglycerides

    Time frame: 12 weeks

  5. Change in total cholesterol (TC)

    Time frame: 12 weeks

  6. Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels

    Time frame: 12 weeks

  7. Change in glucose

    Time frame: 12 weeks

  8. Change in insulin

    Time frame: 12 weeks

  9. Change in glycated hemoglobin (HbA1c)

    Time frame: 12 weeks

  10. Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels

    Time frame: 12 weeks

  11. Change in thyroid function (TSH and Free T4)

    Time frame: 12 weeks

  12. Change in estradiol

    Time frame: 12 weeks

  13. Change in serum metabolome and lipidome

    Time frame: 12 weeks

  14. Change in systolic and diastolic blood pressure

    Time frame: 12 weeks

  15. Change in equol production status

    Time frame: 12 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Ann Popelar

CONTACT

[email protected]

(513) 636-8867

Sponsors and collaborators

Lead sponsor

Marialena Mouzaki

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 15, 2023
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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