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

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Marialena Mouzaki
Study ID
NCT06133101
Phase
PHASE2
Status
Recruiting
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Conditions

  • Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

Sex
ALL
Age
5 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

  • Standard Soy Milk — DRUG
    Consumption of commercially available soy milk
  • 2% Fat Cow's Milk — DRUG
    Consumption of commercially available 2% cow's milk

Study Details

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.

Key Dates

Start date
Jan 15, 2024
Status verified
Aug 2024
Primary completion
Mar 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Ann Popelar
[email protected]
513-636-8867
Marialena Mouzaki, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cincinnati, OH

By research site
Cincinnati Children's Hospital Medical Center· Cincinnati, OH

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