Non-Alcoholic Fatty Liver DiseasePhase 2NCT06133101
Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
A Phase 2 study testing Standard Soy Milk and 2% Fat Cow's Milk in people with Non-Alcoholic Fatty Liver Disease, run by Marialena Mouzaki at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 5 to 16 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Standard Soy Milk and 2% Fat Cow's Milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2024to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with overweight/obesity
- Known NAFLD or elevated ALT (>30)
Who cannot join
- 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
- MRI PDFF <10%
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Ann Popelar, (513) 636-8867, Ann.Popelar@cchmc.org
Marialena Mouzaki, MD
About this study
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
- Being tested
- Standard Soy Milk, 2% Fat Cow's Milk
- Keywords
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Soy MilkDrug
Consumption of commercially available soy milk
2% Fat Cow's MilkDrug
Consumption of commercially available 2% cow's milk
| Study group | Role | What they receive |
|---|---|---|
| 2% Fat Cows Milk | Placebo comparator | Participants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks. Receives: Drug: 2% Fat Cow's Milk |
| Standard Soy Milk | Experimental | Participants randomized to this arm will consume standard soy milk twice daily for 12 weeks. Receives: Drug: Standard Soy Milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in liver disease severity
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.
Measured: 12 weeks
Secondary outcomes (15)
Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])
Measured: 12 weeks
Change in gamma glutamyl-transferase levels (GGT)
Measured: 12 weeks
Change in alkaline phosphatase (ALP)
Measured: 12 weeks
Change in fasting triglycerides
Measured: 12 weeks
Change in total cholesterol (TC)
Measured: 12 weeks
Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels
Measured: 12 weeks
Change in glucose
Measured: 12 weeks
Change in insulin
Measured: 12 weeks
Change in glycated hemoglobin (HbA1c)
Measured: 12 weeks
Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels
Measured: 12 weeks
Change in thyroid function (TSH and Free T4)
Measured: 12 weeks
Change in estradiol
Measured: 12 weeks
Change in serum metabolome and lipidome
Measured: 12 weeks
Change in systolic and diastolic blood pressure
Measured: 12 weeks
Change in equol production status
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start15 Jan 2024
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective parallel arm randomized controlled study
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marialena Mouzaki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marialena Mouzaki, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06133101
- Sponsor's protocol ID
- 2023-0416
- Status last verified
- Mar 2026
- First submitted
- 13 Oct 2023
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Soymilk on Liver Disease Severity of Children With Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT06133101
- Acronym / sponsor ID
- 2023-0416
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Marialena MouzakiUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective parallel arm randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| 2% Fat Cows Milk | Placebo comparator | Drug: 2% Fat Cow's MilkParticipants randomized to this arm will consume 2% fat cow's milk twice daily for 12 weeks. |
| Standard Soy Milk | Experimental | Drug: Standard Soy MilkParticipants randomized to this arm will consume standard soy milk twice daily for 12 weeks. |
Who may qualify
- Ages
- 5 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with overweight/obesity
- Known NAFLD or elevated ALT (>30)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Soy MilkConsumption of commercially available soy milk | Drug | Standard Soy Milk |
| 2% Fat Cow's MilkConsumption of commercially available 2% cow's milk | Drug | 2% Fat Cows Milk |
Primary outcome
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.
15 secondary outcomes
Change in serum aminotransferase levels (ALT, aspartate aminotransferase [AST], GGT, alkaline phosphatase [ALP])
Time frame: 12 weeks
Change in gamma glutamyl-transferase levels (GGT)
Time frame: 12 weeks
Change in alkaline phosphatase (ALP)
Time frame: 12 weeks
Change in fasting triglycerides
Time frame: 12 weeks
Change in total cholesterol (TC)
Time frame: 12 weeks
Change in high- and low-density lipoprotein (HDL-C, LCL-C) levels
Time frame: 12 weeks
Change in glucose
Time frame: 12 weeks
Change in insulin
Time frame: 12 weeks
Change in glycated hemoglobin (HbA1c)
Time frame: 12 weeks
Change in testosterone, estrogen and sex hormone binding globulin (SHBG) levels
Time frame: 12 weeks
Change in thyroid function (TSH and Free T4)
Time frame: 12 weeks
Change in estradiol
Time frame: 12 weeks
Change in serum metabolome and lipidome
Time frame: 12 weeks
Change in systolic and diastolic blood pressure
Time frame: 12 weeks
Change in equol production status
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Standard Soy Milk and 2% Fat Cow's Milk in people with Non-Alcoholic Fatty Liver Disease, run by Marialena Mouzaki at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ann Popelar ((513) 636-8867, Ann.Popelar@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in liver disease severity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.