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Cancer Vaccine

Standard Soy Milk for Non-alcoholic Fatty Liver Disease

Phase 2
Recruiting
Research Sponsored by Marialena Mouzaki
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with non-alcoholic fatty liver disease (NAFLD) and an MRI PDFF >10%
Patients with known NAFLD or elevated ALT for sex (>22 for females and >26 for males)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

Study Summary

"This trial will compare the effects of drinking soy milk versus cow's milk in children with Non-alcoholic Fatty Liver Disease (NAFLD). Researchers believe that the soy isoflavones in soy

Who is the study for?
This trial is for children with non-alcoholic fatty liver disease (NAFLD) who are overweight or obese. They must have an MRI PDFF >10% and elevated ALT levels (>22 for females, >26 for males).Check my eligibility
What is being tested?
The study compares the effects of drinking standard soy milk versus 2% fat cow's milk on the severity of NAFLD in children. It aims to see if soy isoflavones in soy milk can help reduce liver disease.See study design
What are the potential side effects?
No adverse endocrine or metabolomic side effects from consuming soy isoflavones are expected according to the investigators' hypothesis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have NAFLD with a liver fat level over 10% on MRI.
Select...
I have NAFLD or my ALT levels are high for my sex.
Select...
My child is overweight or obese.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in liver disease severity
Secondary outcome measures
Change in alkaline phosphatase (ALP)
Change in equol production status
Change in estradiol
+12 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard Soy MilkExperimental Treatment1 Intervention
Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks.
Group II: 2% Fat Cows MilkPlacebo Group1 Intervention
Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks.

Find a Location

Who is running the clinical trial?

Marialena MouzakiLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers currently seeking participants for this study?

"As per the information available on clinicaltrials.gov, this current trial is actively searching for eligible participants. The study was first listed on January 15th, 2024 and has been recently revised as of March 10th, 2024."

Answered by AI

Am I eligible to be a participant in this clinical trial?

"In this study, enrollment is open to 44 individuals aged between 5 and 12 diagnosed with non-alcoholic fatty liver disease (NAFLD). Eligible participants must meet the following conditions: a diagnosis of NAFLD confirmed by MRI PDFF >10%, children classified as overweight or obese, and documented NAFLD or elevated ALT levels exceeding >22 for females and >26 for males."

Answered by AI

Are individuals above the age of fifty eligible to participate in this research study?

"Eligible candidates for this research endeavor must fall within the age bracket of 5 to 12 years old. While there are numerous trials available for individuals under 18 and over 65, specifically there are 34 studies targeting minors and 329 aimed at older adults."

Answered by AI

Does the FDA endorse traditional soy milk?

"Given that this investigation is categorized as a Phase 2 trial, the safety rating for Standard Soy Milk has been determined to be a level 2 by our team at Power. This indicates that while there exists some evidence of its safety profile, data supporting efficacy remains lacking."

Answered by AI

What is the current number of individuals being admitted into this research investigation?

"Affirmative. Information available on clinicaltrials.gov indicates that this investigation is actively seeking suitable participants. The study was initially uploaded on January 15, 2024, and last revised on March 10, 2024. They aim to enroll a total of 44 patients from one designated site."

Answered by AI
~29 spots leftby Mar 2026