MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseNCT07090083
Pediatric Metabolic Dysfunction-associated Steatotic Liver Disease and Food Insecurity
An observational study of MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity, run by University of California, San Francisco at 1 site in United States.
Trial summary
This proposal addresses a critical gap in our understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Food Insecurity
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2025to 30 Dec 2026
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with MASLD with and without exposure to household food insecurity.
Who may be able to join
- Children and adolescents receiving care in the liver and WATCH clinics.
- Family living in California.
- Parent/guardian speaks Spanish or English.
- Child is between the ages of 6 to <17 years.
- Elevated ALT on at least 2 occasions within the past year:
- ALT > 22 units/L for females.
Show all 12Show fewer
- ALT > 26 units/L for males.
- BMI for age/sex ≥ 85%.
- Alternatively, child has one elevated ALT within the past year and confirmed steatosis on imaging.
- Family does not intend to move out of California within the next year.
- Family is not already receiving EatSF SF Fruit and Vegetable Vouchers.
- Family is not participating in any other dietary education programs besides those offered by the WATCH or liver clinics.
Who cannot join
- Child has an underlying condition or medication causing their weight gain (e.g., hypothyroidism, Prader-Willi syndrome, antipsychotic medications).
- Child is on, or expected to go on, or starts on a weight loss medication (e.g., Qsymia or GLP-1 receptor agonists).
- Child has another known cause of liver disease (not including MASLD or MASH), such as:
- Autoimmune hepatitis.
- Wilson's disease.
- Hepatitis A, B, or C.
- Acute infection.
- Genetic condition causing inflammation in the liver.
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
University of California, San Francisco
San Francisco, California, 94158
Sarah L Maxwell, MD, 415-519-7863, sarah.maxwell@ucsf.edu
Sarah L Maxwell, MD
About this study
Official title: Pediatric MASLD and Food Insecurity
This proposal addresses a critical gap in our understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. There is evidence that children in families that do not have the ability to provide consistently healthy and high-quality foods, such as fruits and vegetables, have worse diet quality that children in households that are food secure. Additionally, evidence from adult studies link household FI to MASLD and liver fibrosis, and prior research of the PI has shown that exposure to household FI in early childhood was associated with a nearly 4 times increased odds of pediatric MASLD in middle childhood. Possible mechanisms linking household FI to pediatric MASLD include lower intake of fruits and vegetables, higher intake of caloric dense nutrient poor foods (e.g., sugar sweetened beverages), and less diversity of foods. Given consensus recommendations for the management of MASLD focus on lifestyle modification, i.e., diet and exercise to achieve weight loss, this proposal seeks to explore the association of household FI and pediatric MASLD disease severity and whether those effects are mediated by dietary intake. Study participants include children/adolescents with MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic.
Read the detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD) is now the most common type of chronic liver disease among children and adolescents in the US, with the highest burden among children from low-income families, those with obesity, and those who are Hispanic. MASLD describes a spectrum of liver injury from simple hepatic steatosis to steatohepatitis, which can progress to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver failure. MASLD is one of the leading indications for liver transplantation in adults. Emerging evidence in adults links household FI to MASLD, liver fibrosis, and mortality. FI is defined by the US Department of Agriculture (USDA) as a state in which there is "limited or uncertain availability of nutritionally adequate and safe foods or limited or uncertain ability to acquire foods in socially acceptable ways." Adults with MASLD and FI have been shown to have poor diet quality that is significantly associated with fibrosis.
Research has found that household FI is highly prevalent in families with children. Fifteen percent of U.S. households, and 30% of San Francisco households with children are food insecure, which limits the ability of these families to consistently provide healthy, high-quality food. Research has found that children living in food insecure households have worse diet quality with regard to specific food categories compared to those in food secure households. Specifically children in food insecure households consume fewer fruits and vegetables (F\&V), and more SSBs. Children in households with severe FI have worse overall diet quality than those who are food secure.
Researchers, including the PI (see preliminary studies below), have found that exposure to household FI in children/adolescents is associated with pediatric MASLD. Given current consensus recommendations for the management of pediatric MASLD focus on lifestyle interventions, i.e., diet and physical activity), this project will assess the association of household FI and MASLD disease severity and whether these effects are mediated by dietary intake.
- Keywords
- MASLD, food insecurity, pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Food secure | Children with MASLD with exposure to household food security | |
| Food insecure | Children with MASLD with exposure to household food insecurity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alanine aminotransferase (ALT)
Alanine aminotransferase (ALT)
Measured: 30 days
Gamma-glutamyl transferase (GGT)
Gamma-glutamyl transferase (GGT)
Measured: 30 days
Secondary outcomes (2)
Dietary intake of fruits and vegetables
Dietary intake of fruit and vegetables
Measured: 30 days
dietary intake of SSBs
Dietary intake of sugar sweetened beverages
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start30 Jul 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for MASLD - Metabolic Dysfunction-Associated Steatotic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- American Gastroenterological Association Foundation, UCSF Population Health Health Equity Award
- Responsible party
- Sponsor
- Investigators
- Sarah L Maxwell, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090083
- Sponsor's protocol ID
- 23-40614
- Status last verified
- Aug 2025
- First submitted
- 22 Jul 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Golovaty I, Tien PC, Price JC, Sheira L, Seligman H, Weiser SD. Food Insecurity May Be an Independent Risk Factor Associated with Nonalcoholic Fatty Liver Disease among Low-Income Adults in the United States. J Nutr. 2020 Jan 1;150(1):91-98. doi: 10.1093/jn/nxz212.
PubMed 31504710Tamargo JA, Sherman KE, Campa A, Martinez SS, Li T, Hernandez J, Teeman C, Mandler RN, Chen J, Ehman RL, Baum MK. Food insecurity is associated with magnetic resonance-determined nonalcoholic fatty liver and liver fibrosis in low-income, middle-aged adults with and without HIV. Am J Clin Nutr. 2021 Mar 11;113(3):593-601. doi: 10.1093/ajcn/nqaa362.
PubMed 33515016Kardashian A, Dodge JL, Terrault NA. Food Insecurity is Associated With Mortality Among U.S. Adults With Nonalcoholic Fatty Liver Disease and Advanced Fibrosis. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2790-2799.e4. doi: 10.1016/j.cgh.2021.11.029. Epub 2021 Dec 16.
PubMed 34958747Kardashian A, Dodge JL, Terrault NA. Racial and ethnic differences in diet quality and food insecurity among adults with fatty liver and significant fibrosis: a U.S. population-based study. Aliment Pharmacol Ther. 2022 Nov;56(9):1383-1393. doi: 10.1111/apt.17219. Epub 2022 Sep 29.
PubMed 36173037Landry MJ, van den Berg AE, Asigbee FM, Vandyousefi S, Ghaddar R, Davis JN. Child-Report of Food Insecurity Is Associated with Diet Quality in Children. Nutrients. 2019 Jul 12;11(7):1574. doi: 10.3390/nu11071574.
PubMed 31336880Maxwell SL, Price JC, Perito ER, Rosenthal P, Wojcicki JM. Food insecurity is a risk factor for metabolic dysfunction-associated steatotic liver disease in Latinx children. Pediatr Obes. 2024 Jun;19(6):e13109. doi: 10.1111/ijpo.13109. Epub 2024 Mar 7.
PubMed 38453472
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric MASLD and Food Insecurity
- ClinicalTrials.gov ID
- NCT07090083
- Acronym / sponsor ID
- 23-40614
- Keywords
- MASLD, food insecurity, pediatric
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- American Gastroenterological Association Foundation, UCSF Population Health Health Equity Award
- Study start
- 30 Jul 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Jul 2025 (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 proposal addresses a critical gap in our understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. There is evidence that children in families that do not have the ability to provide consistently healthy and high-quality foods, such as fruits and vegetables, have worse diet quality that children in households that are food secure. Additionally, evidence from adult studies link household FI to MASLD and liver fibrosis, and prior research of the PI has shown that exposure to household FI in early childhood was associated with a nearly 4 times increased odds of pediatric MASLD in middle childhood. Possible mechanisms linking household FI to pediatric MASLD include lower intake of fruits and vegetables, higher intake of caloric dense nutrient poor foods (e.g., sugar sweetened beverages), and less diversity of foods. Given consensus recommendations for the management of MASLD focus on lifestyle modification, i.e., diet and exercise to achieve weight loss, this proposal seeks to explore the association of household FI and pediatric MASLD disease severity and whether those effects are mediated by dietary intake. Study participants include children/adolescents with MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic.
Detailed description
Metabolic dysfunction-associated steatotic liver disease (MASLD) is now the most common type of chronic liver disease among children and adolescents in the US, with the highest burden among children from low-income families, those with obesity, and those who are Hispanic. MASLD describes a spectrum of liver injury from simple hepatic steatosis to steatohepatitis, which can progress to liver fibrosis, cirrhosis, hepatocellular carcinoma, and liver failure. MASLD is one of the leading indications for liver transplantation in adults. Emerging evidence in adults links household FI to MASLD, liver fibrosis, and mortality. FI is defined by the US Department of Agriculture (USDA) as a state in which there is "limited or uncertain availability of nutritionally adequate and safe foods or limited or uncertain ability to acquire foods in socially acceptable ways." Adults with MASLD and FI have been shown to have poor diet quality that is significantly associated with fibrosis.
Research has found that household FI is highly prevalent in families with children. Fifteen percent of U.S. households, and 30% of San Francisco households with children are food insecure, which limits the ability of these families to consistently provide healthy, high-quality food. Research has found that children living in food insecure households have worse diet quality with regard to specific food categories compared to those in food secure households. Specifically children in food insecure households consume fewer fruits and vegetables (F\&V), and more SSBs. Children in households with severe FI have worse overall diet quality than those who are food secure.
Researchers, including the PI (see preliminary studies below), have found that exposure to household FI in children/adolescents is associated with pediatric MASLD. Given current consensus recommendations for the management of pediatric MASLD focus on lifestyle interventions, i.e., diet and physical activity), this project will assess the association of household FI and MASLD disease severity and whether these effects are mediated by dietary intake.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Food secure | – | –Children with MASLD with exposure to household food security |
| Food insecure | – | –Children with MASLD with exposure to household food insecurity |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with MASLD with and without exposure to household food insecurity.
Key inclusion criteria (12 listed)
- Children and adolescents receiving care in the liver and WATCH clinics.
- Family living in California.
- Parent/guardian speaks Spanish or English.
- Child is between the ages of 6 to <17 years.
- Elevated ALT on at least 2 occasions within the past year:
Key exclusion criteria (8 listed)
- Child has an underlying condition or medication causing their weight gain (e.g., hypothyroidism, Prader-Willi syndrome, antipsychotic medications).
- Child is on, or expected to go on, or starts on a weight loss medication (e.g., Qsymia or GLP-1 receptor agonists).
- Child has another known cause of liver disease (not including MASLD or MASH), such as:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Alanine aminotransferase (ALT)
Time frame: 30 days
Alanine aminotransferase (ALT)
Gamma-glutamyl transferase (GGT)
Time frame: 30 days
Gamma-glutamyl transferase (GGT)
2 secondary outcomes
Dietary intake of fruits and vegetables
Time frame: 30 days
dietary intake of SSBs
Time frame: 30 days
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 2 Sep 2025.
- Background: PubMed 31504710Golovaty I, Tien PC, Price JC, Sheira L, Seligman H, Weiser SD. Food Insecurity May Be an Independent Risk Factor Associated with Nonalcoholic Fatty Liver Disease among Low-Income Adults in the United States. J Nutr. 2020 Jan 1;150(1):91-98. doi: 10.1093/jn/nxz212.
- Background: PubMed 33515016Tamargo JA, Sherman KE, Campa A, Martinez SS, Li T, Hernandez J, Teeman C, Mandler RN, Chen J, Ehman RL, Baum MK. Food insecurity is associated with magnetic resonance-determined nonalcoholic fatty liver and liver fibrosis in low-income, middle-aged adults with and without HIV. Am J Clin Nutr. 2021 Mar 11;113(3):593-601. doi: 10.1093/ajcn/nqaa362.
- Background: PubMed 34958747Kardashian A, Dodge JL, Terrault NA. Food Insecurity is Associated With Mortality Among U.S. Adults With Nonalcoholic Fatty Liver Disease and Advanced Fibrosis. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2790-2799.e4. doi: 10.1016/j.cgh.2021.11.029. Epub 2021 Dec 16.
- Background: PubMed 36173037Kardashian A, Dodge JL, Terrault NA. Racial and ethnic differences in diet quality and food insecurity among adults with fatty liver and significant fibrosis: a U.S. population-based study. Aliment Pharmacol Ther. 2022 Nov;56(9):1383-1393. doi: 10.1111/apt.17219. Epub 2022 Sep 29.
- Background: PubMed 31336880Landry MJ, van den Berg AE, Asigbee FM, Vandyousefi S, Ghaddar R, Davis JN. Child-Report of Food Insecurity Is Associated with Diet Quality in Children. Nutrients. 2019 Jul 12;11(7):1574. doi: 10.3390/nu11071574.
- Background: PubMed 38453472Maxwell SL, Price JC, Perito ER, Rosenthal P, Wojcicki JM. Food insecurity is a risk factor for metabolic dysfunction-associated steatotic liver disease in Latinx children. Pediatr Obes. 2024 Jun;19(6):e13109. doi: 10.1111/ijpo.13109. Epub 2024 Mar 7.
- Individual participant dataSharing planned: No
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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.
Sarah L Maxwell, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease and Food Insecurity, run by University of California, San Francisco 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 12 inclusion and 8 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 2 Sep 2025. 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?
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 Milagro Escobar (415-519-7863, milagro.escobar@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alanine aminotransferase (ALT) (time frame: 30 days). 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 NCT07090083, which also lists 6 linked publications.
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 Sep 2025.