Non-Alcoholic Fatty Liver DiseaseNCT05292352
Prevention of NAFLD in Hispanic Children
A study testing LFSD in people with Non-Alcoholic Fatty Liver Disease, run by Emory University at 1 site in United States.
Trial summary
This is a 2 year clinical trial testing an intensive intervention to reduce dietary sugars as a means to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- LFSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2022to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least one parent or the child self-identifies as Hispanic or Latino.
- BMI ≥ 50th percentile for age and sex.
- Age ≥ 6 years and ≤ 9 years
- Tanner stage 1 by self and/or parental report
- Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)
- Written informed consent from parent or legal guardian, assent from child
Who cannot join
- Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"
- History of significant depression
- Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI
- Type 2 diabetes (Hemoglobin A1c > 6.4% on screening labs or chronic diagnosis)
- Plans to move within the next 12 months
- Current or previous participation in a weight loss program or obesity treatment program or clinic
Show all 14Show fewer
- Cancer or history of cancer
- Recipient of a liver transplant
- Chronic use (in the last year) of medications known to cause NAFLD or fatty liver (TPN, amiodarone, chronic oral steroids, etc.)
- Intellectual disability or major psychiatric disorder limiting informed assent
- At risk for eating disorder by screening instrument
- Participants who are currently enrolled in a clinical trial or have received an investigational product within the last 60 days
- Participants who are not able or willing to comply with the diet protocol or have any other condition or circumstance that would impede compliance or hinder completion of the study in the opinion of the investigator
- Children who spend more than 1 night per week consistently in another household
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanic Children
This is a 2 year clinical trial testing an intensive intervention to reduce dietary sugars as a means to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children.
Read the detailed description
The number of children experiencing obesity and the chronic diseases associated with it has risen dramatically in recent decades. This includes non-alcoholic fatty liver disease (NAFLD). NAFLD is an excess accumulation of fat in the liver that results when children's diet and activity patterns compound the genetic risk they were born with. Excess fat in the liver increases the risk of diabetes and heart disease, as well as the chance that a liver transplant will be needed. Previous studies suggest that diets high in sugar, particularly during critical periods of development, increase children's risk of developing NAFLD. The study team has previously shown that reducing intake of free sugars (those used to sweeten foods and beverages and those found naturally in fruit juices) to very low levels reduce the amount of fat stored in the liver and improves the metabolic health of children with NAFLD.
This single-site randomized clinical trial is designed to determine if following a diet very low in free sugars just before puberty, a time of increased metabolic disruption, can help to prevent NAFLD in children known to be at high risk. This trial will study free-living Hispanic children with overweight or obesity because their increased risk for NAFLD compared to non-Hispanic children has been well documented. Enrollment will include children ages 6-9 years and Tanner stage 1 living in the Atlanta metropolitan area. Recruitment is through local pediatric clinics and through parents attending diabetes and NAFLD clinics. Enrollment and informed consent are performed by members of the research team. The one-year dietary intervention will include a combination of evidence-based strategies: dietary counseling by a nutritionist using motivational interviewing and family-centered goal setting; a one-month provision of a low/free sugar diet for the entire family, and nutritionist-guided (and study-funded) grocery shopping trips every 3 months thereafter. The control group will follow their usual diet and receive similar study assessments and compensation.
The primary outcome at year one is MRI-assessed change in the amount of liver fat from baseline. At 24 months, the incidence of NAFLD in the intervention group vs. the control group will be assessed (primary outcome of the 24-month study). Other outcomes to be assessed at 12- and 24-months include changes in liver enzymes, glucose metabolism, dyslipidemia, body composition, and metabolomics.
These studies may inform the development of guidelines for clinicians, dietitians, parents, and others involved in counseling and caring for children at high risk of developing NAFLD.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- LFSD
- Keywords
- Latino Children, Pre-puberal, Low Free sugar diet (LFSD)
- 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.
LFSDBehavioural
Assessment of child's usual diet to assess sugar intake in relation to the total usual diet.
Consultation with a nutritionist to help families identify foods high in sugar. Removal of foods and drinks high in free sugar from the home.
Counseling using motivational interviewing, patient-centered goal setting to help parents and participating youth identify barriers to compliance with the intervention. Provision of a study provided LFSD with sufficient quantity to meet the needs and adapted to meet the preferences of the entire household for the first 4 weeks. Facilitated grocery shopping trips every 3 months during year 1.
| Study group | Role | What they receive |
|---|---|---|
| Low Free Sugar Diet (LFSD) Intervention | Experimental | The 1-year dietary intervention will be accomplished by adapting and extending a Social Cognitive Theory (SCT) guided low sugar intervention. SCT is a framework that helps explain how people regulate their behavior through control and reinforcement to achieve goal-directed behavior that can be maintained over time. Receives: Behavioral: LFSD |
| Usual Care Control | No intervention | Usual Care (Control group): Parents of enrolled children in the usual care group will be provided printed material on healthy family lifestyle at the beginning of the study. The control group will complete all of the same research visits and assessments as the intervention group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent Hepatic Steatosis by by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
The primary objective for the 12-month study is to test if an LFSD, compared to usual diet protects against increase in hepatic steatosis
Measured: 12 month after start of intervention
Onset of NAFLD
The primary objective for the 24-month is to study to test if an LFSD protects against development of NAFLD (hepatic steatosis ≥ 5% and elevated ALT).
Measured: up to 24 months after start of intervention
Secondary outcomes (12)
Markers of liver inflammation: Alanine Transaminase (ALT)
ALT will be measured from comprehensive metabolic panel (CMP) lab test and compared
Measured: Baseline, month 6, month 12, month 18, and month 24
Markers of liver inflammation: aspartate aminotransferase (AST)
AST will be measured from CMP lab test and compared
Measured: Baseline, month 6, month 12, month 18, and month 24
Markers of liver inflammation: gamma-glutamyltransferase (GGT)
Laboratory tests will be collected and values compared
Measured: Baseline, month 12 and month 24
Changes in HbA1c
Changes in HbA1c will be reviewed by a physician study investigator for patient safety. If patients develop clinically relevant abnormalities, the results will be provided to the pediatrician of the child or other provider as directed by the parents/guardians.
Measured: Baseline, month 12 and month 24
Changes in fasting triglycerides
Fasting lipid panels will be performed at each visit. Frozen plasma will be shipped to LabCorp for NMR lipoprotein particle size measurement, extended lipid profiles, and GlycA measurement.
Measured: Baseline, Month 6, Month 12, month 18 and month 24
Changes in Fasting insulin
Measured before the OGTT study
Measured: Measured at baseline, month 12 and month 24
Changes in HDL
Fasting lipid panels will be performed at each visit. Frozen plasma will be shipped to LabCorp for NMR lipoprotein particle size measurement, extended lipid profiles and GlycA measurement.
Measured: Baseline, Month 6, Month 12, month 18 and month 24
Changes in LDL
Fasting lipid panels will be performed at each visit. Frozen plasma will be shipped to LabCorp for NMR lipoprotein particle size measurement, extended lipid profiles and GlycA measurement.
Measured: Baseline, Month 6, Month 12, month 18 and month 24
Changes in waist hip ratio
BMI will be calculated from weight and height measured twice and averaged. Waist and hip measurements will be performed.
Measured: Baseline, month 12 and month 24
Changes in BMI
BMI and BMI percentile will be calculated from weight and height measured twice and averaged.
Measured: Baseline, month 12 and month 24
Changes in Neck acanthosis nigricans
Acanthosis nigricans (AN) monitoring: To improve objective assessment, AN will be captured using a photo of the neck base and by standardized assessment (scale 0 to 4) by the study coordinator or the investigator. Will be assessed by the "Neck Acanthosis Severity Scale" that ranges from 0-4.
Measured: Baseline, month 12 and month 24
Changes Oral Glucose tolerance test (OGTT)
An oral glucose tolerance test (OGTT) will be performed for measures of adipose and peripheral IR. After the IV is placed, the fasting labs will be drawn from it. For the OGTT, we will perform frequent sampling of glucose and insulin and store blood for additional assays such as free fatty acid (FFA )and C-peptide. Bloods will be drawn using an 8-sample schedule after consumption of the glucose beverage (0, 10, 20, 30, 60, 90, 120, and 180 min). The OGTT beverage will consist of 50 g plus an additional 40 mg/kg of glucose. Whole body insulin sensitivity (Si) will be calculated with a 4-hour oral minimal model, utilizing SAM II software137. Adipose IR will be calculated as the FFA nadir, as in our preliminary data.
Measured: Baseline, month 12 and month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start6 Apr 2022
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Why it stopped: Study was terminated due to a lack of funding. Data collection was completed for 12-month outcomes; however, funding limitations prevented follow-up for longer timeframes, and some outcomes were not fully collected.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jean Welsh, Emory University
- Investigators
- Jean Welsh, PhD, MPH, RN, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292352
- Sponsor's protocol ID
- STUDY00002076
- Other IDs
- 1R01NR019083-01A1, 2025P010571
- Status last verified
- May 2026
- First submitted
- 15 Mar 2022
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data underlying published findings
Publications
Welsh JA, Pyo E, Huneault H, Gonzalez Ramirez L, Alazraki A, Alli R, Dunbar SB, Khanna G, Knight-Scott J, Pimentel A, Reed B, Rodney-Somersall C, Santoro N, Umpierrez G, Vos MB. Study protocol for a randomized, controlled trial using a novel, family-centered diet treatment to prevent nonalcoholic fatty liver disease in Hispanic children. Contemp Clin Trials. 2023 Jun;129:107170. doi: 10.1016/j.cct.2023.107170. Epub 2023 Apr 3.
PubMed 37019180
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanic Children
- ClinicalTrials.gov ID
- NCT05292352
- Acronym / sponsor ID
- STUDY00002076
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Latino Children, Pre-puberal, Low Free sugar diet (LFSD)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to a lack of funding. Data collection was completed for 12-month outcomes; however, funding limitations prevented follow-up for longer timeframes, and some outcomes were not fully collected.
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 23 Mar 2022 (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.
This is a 2 year clinical trial testing an intensive intervention to reduce dietary sugars as a means to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children.
Detailed description
The number of children experiencing obesity and the chronic diseases associated with it has risen dramatically in recent decades. This includes non-alcoholic fatty liver disease (NAFLD). NAFLD is an excess accumulation of fat in the liver that results when children's diet and activity patterns compound the genetic risk they were born with. Excess fat in the liver increases the risk of diabetes and heart disease, as well as the chance that a liver transplant will be needed. Previous studies suggest that diets high in sugar, particularly during critical periods of development, increase children's risk of developing NAFLD. The study team has previously shown that reducing intake of free sugars (those used to sweeten foods and beverages and those found naturally in fruit juices) to very low levels reduce the amount of fat stored in the liver and improves the metabolic health of children with NAFLD.
This single-site randomized clinical trial is designed to determine if following a diet very low in free sugars just before puberty, a time of increased metabolic disruption, can help to prevent NAFLD in children known to be at high risk. This trial will study free-living Hispanic children with overweight or obesity because their increased risk for NAFLD compared to non-Hispanic children has been well documented. Enrollment will include children ages 6-9 years and Tanner stage 1 living in the Atlanta metropolitan area. Recruitment is through local pediatric clinics and through parents attending diabetes and NAFLD clinics. Enrollment and informed consent are performed by members of the research team. The one-year dietary intervention will include a combination of evidence-based strategies: dietary counseling by a nutritionist using motivational interviewing and family-centered goal setting; a one-month provision of a low/free sugar diet for the entire family, and nutritionist-guided (and study-funded) grocery shopping trips every 3 months thereafter. The control group will follow their usual diet and receive similar study assessments and compensation.
The primary outcome at year one is MRI-assessed change in the amount of liver fat from baseline. At 24 months, the incidence of NAFLD in the intervention group vs. the control group will be assessed (primary outcome of the 24-month study). Other outcomes to be assessed at 12- and 24-months include changes in liver enzymes, glucose metabolism, dyslipidemia, body composition, and metabolomics.
These studies may inform the development of guidelines for clinicians, dietitians, parents, and others involved in counseling and caring for children at high risk of developing NAFLD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Free Sugar Diet (LFSD) Intervention | Experimental | Behavioral: LFSDThe 1-year dietary intervention will be accomplished by adapting and extending a Social Cognitive Theory (SCT) guided low sugar intervention. SCT is a framework that helps explain how people regulate their behavior through control and reinforcement to achieve goal-directed behavior that can be maintained over time. |
| Usual Care Control | No intervention | –Usual Care (Control group): Parents of enrolled children in the usual care group will be provided printed material on healthy family lifestyle at the beginning of the study. The control group will complete all of the same research visits and assessments as the intervention group. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- At least one parent or the child self-identifies as Hispanic or Latino.
- BMI ≥ 50th percentile for age and sex.
- Age ≥ 6 years and ≤ 9 years
- Tanner stage 1 by self and/or parental report
- Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)
Key exclusion criteria (14 listed)
- Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"
- History of significant depression
- Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI
- Type 2 diabetes (Hemoglobin A1c > 6.4% on screening labs or chronic diagnosis)
- Plans to move within the next 12 months
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 |
|---|---|---|
| LFSDAssessment of child's usual diet to assess sugar intake in relation to the total usual diet. Consultation with a nutritionist to help families identify foods high in sugar. Removal of foods and drinks high in free sugar from the home. Counseling using motivational interviewing, patient-centered goal setting to help parents and participating youth identify barriers to compliance with the intervention. Provision of a study provided LFSD with sufficient quantity to meet the needs and adapted to meet the preferences of the entire household for the first 4 weeks. Facilitated grocery shopping trips every 3 months during year 1. | Behavioural | Low Free Sugar Diet (LFSD) Intervention |
Primary outcome
Change in Percent Hepatic Steatosis by by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame: 12 month after start of intervention
The primary objective for the 12-month study is to test if an LFSD, compared to usual diet protects against increase in hepatic steatosis
Onset of NAFLD
Time frame: up to 24 months after start of intervention
The primary objective for the 24-month is to study to test if an LFSD protects against development of NAFLD (hepatic steatosis ≥ 5% and elevated ALT).
12 secondary outcomes
Markers of liver inflammation: Alanine Transaminase (ALT)
Time frame: Baseline, month 6, month 12, month 18, and month 24
Markers of liver inflammation: aspartate aminotransferase (AST)
Time frame: Baseline, month 6, month 12, month 18, and month 24
Markers of liver inflammation: gamma-glutamyltransferase (GGT)
Time frame: Baseline, month 12 and month 24
Changes in HbA1c
Time frame: Baseline, month 12 and month 24
Changes in fasting triglycerides
Time frame: Baseline, Month 6, Month 12, month 18 and month 24
Changes in Fasting insulin
Time frame: Measured at baseline, month 12 and month 24
Changes in HDL
Time frame: Baseline, Month 6, Month 12, month 18 and month 24
Changes in LDL
Time frame: Baseline, Month 6, Month 12, month 18 and month 24
Changes in waist hip ratio
Time frame: Baseline, month 12 and month 24
Changes in BMI
Time frame: Baseline, month 12 and month 24
Changes in Neck acanthosis nigricans
Time frame: Baseline, month 12 and month 24
Changes Oral Glucose tolerance test (OGTT)
Time frame: Baseline, month 12 and month 24
Results and safety
The study was stopped early (reason given: Study was terminated due to a lack of funding. Data collection was completed for 12-month outcomes; however, funding limitations prevented follow-up for longer timeframes, and some outcomes were not fully collected.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 37019180Welsh JA, Pyo E, Huneault H, Gonzalez Ramirez L, Alazraki A, Alli R, Dunbar SB, Khanna G, Knight-Scott J, Pimentel A, Reed B, Rodney-Somersall C, Santoro N, Umpierrez G, Vos MB. Study protocol for a randomized, controlled trial using a novel, family-centered diet treatment to prevent nonalcoholic fatty liver disease in Hispanic children. Contemp Clin Trials. 2023 Jun;129:107170. doi: 10.1016/j.cct.2023.107170. Epub 2023 Apr 3.
- Individual participant dataSharing planned: Yes. De-identified data underlying published findings
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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. This study is not recruiting at the moment.
Jean Welsh, PhD, MPH, RN principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LFSD in people with Non-Alcoholic Fatty Liver Disease, run by Emory University 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 6 inclusion and 14 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: stopped early, as of the sponsor's last update on 2 Jun 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to a lack of funding. Data collection was completed for 12-month outcomes; however, funding limitations prevented follow-up for longer timeframes, and some outcomes were not fully collected.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent Hepatic Steatosis by by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) (time frame: 12 month after start of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05292352, which also lists 1 linked publication.
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 2 Jun 2026.