NAFLDHEROESNCT02948647
Healthy Eating Through Reduction Of Excess Sugar
A study of NAFLD, run by University of Southern California at 2 sites in United States.
Trial summary
The purpose of the study is to determine the effect of dietary sugar reduction in obese children and examine whether there are differential effects based on genotype of a single amino acid substitution in the PNPLA3 gene that is highly prevalent in Hispanics and associated with significantly elevated liver fat. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- NAFLD
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2016to Nov 2021
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Ethnicity: This study is limited to Hispanics because of their higher risk of NAFLD, higher frequency (~50%) of the at-risk PNPLA3 allele (G), and because no prior studies have targeted improvement in liver fat and NAFLD in this high-risk population. As with all of our ongoing studies, Hispanic ethnicity will be based on self-identity for the participants as well as their parents and grandparents.
- Gender: Males and females will be eligible for this study.
- Age: Children 12 to 18 years of age will be eligible. In our experience, children younger than around 10 years of age and greater than 18 years would require different intervention/counseling strategies. Therefore, we can develop a more consistent "age-neutral" approach if we limit the age range to 12-18 years.
- Weight status: Subjects will be eligible if they are obese, defined by a BMI > 95th percentile for age and gender.
Who cannot join
- Diabetes: Presence of type 1 or 2 diabetes, as defined by fasting plasma glucose > 126 mg/dl, or positive for diabetes related antibodies including ICA512 and GAD. Participants testing positive for diabetes will be referred for treatment. Subjects with pre-diabetes will be eligible for the study
- Pregnancy: Women who self-report as pregnant or obtain a positive pregnancy test result during Visit 1 will be excluded. Furthermore, should a woman become pregnant during the course of the intervention, she will be withdrawn from the study at that time and asked to no longer participate. This is in order to protect the mother and child from radiation involved with the DEXA scan and potential complications associated with a low-sugar diet.
- Medication: Taking any medications known to influence liver function, insulin action or lipid levels
- Self-prescribed dietary supplements: Taking any non-prescription supplements that could potentially affect liver function and liver fat (eg vitamin E or fish oils)
- Other metabolic diseases: Diagnosis of other syndromes or diseases that may influence insulin action and secretion (e.g., maturity-onset diabetes of the young, lipoatrophic diabetes, cystic fibrosis), or body composition and fat distribution (e.g. Cushing syndrome, Down syndrome, lipodystrophy)
- Other medical condition: Previously diagnosed with any major illness since birth (e.g. severe intrauterine growth retardation, chronic birth asphyxia, cancer)
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- Familial hyperlipidemia: Patients with a family history of hyperlipidemia will be excluded, due to the particular genetic background of this disease, which may bias our results. Familial hyperlipidemia will be defined as LDL/cholesterol > 160 mg/dL and/or triglycerides > 200 mg/dL in both the participant AND at least one family member (first degree: parents or siblings).
- Smoking or drinking: Self-reported current smoking participants (more than 1 cigarette in the past week) will be excluded due to the potential effect of smoking on weight control and inflammatory status. Consumption of alcohol on a regular basis (40g/day alcohol per day determined by questionnaire) will also be excluded due to its important role in liver disease. Use of recreational drugs will also be an exclusion criteria, due to the potent effect of cannabinoids receptors on weight status and food intake.
- Participation in a weight-loss or exercise program: participants who have participated to a weight-loss or exercise program in the past three months will be excluded due to its potential effect on weight status.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Los Angeles
Los Angeles, California, 90027
Diabetes & Obesity Research Institute
Los Angeles, California, 90033-9073
About this study
Official title: Diets Based on PNPLA3 Genotype for Reducing Liver Fat in Hispanics With Pediatric Non-alcoholic Fatty Liver Disease
The purpose of the study is to determine the effect of dietary sugar reduction in obese children and examine whether there are differential effects based on genotype of a single amino acid substitution in the PNPLA3 gene that is highly prevalent in Hispanics and associated with significantly elevated liver fat.
Read the detailed description
This dietary intervention aims at developing a more personalized and targeted treatment for NAFLD in Hispanic children and adolescents who are GG for the PNPLA3 variant. The investigators previous publications have shown that this particular demographic has a greater than 2-fold higher liver fat compared to GC and CC individuals. They have also demonstrated a significant gene*dietary sugar interaction with a significant association between liver fat and dietary sugar intake in GG subjects with no such association in GC or CC individuals. These studies suggests that different dietary strategies may have differential effects on reducing liver fat, depending on PNPLA3 genotype. To confirm this, the investigators will complete a clinical trial in 120 overweight and obese Hispanic children (12 - 18 years) with clinically verified NAFLD who will be randomized to one of two 12-week interventions:
Group 1 (standard of care control group): Dietary intervention focused on healthy eating (n=60; 30GG + 30GC/CC)
Group 2 (standard of care + sugar reduction): Dietary intervention based on healthy eating and sugar reduction focused on reduction of sugary beverages and added sugar towards a goal of 10% of daily calories (n=60; 30GG + 30GC/CC)
The following outcomes will be measured before and after intervention: Total liver fat fraction, and visceral and subcutaneous abdominal adipose tissue volume by magnetic resonance imaging (MRI); liver fibrosis by magnetic resonance elastography (MRE); total body fat by DEXA; liver enzymes, fasting insulin, glucose, lipids, free fatty acids and inflammatory markers, gut microbiome, and insulin and glucose response to an oral glucose challenge. The investigators hypothesize that liver fat fraction, liver fibrosis, and metabolic outcomes, such as fasting and 2h-glucose and insulin, and inflammatory biomarkers, will show significantly greater improvements with sugar reduction relative to control. In addition, the investigators also hypothesize a treatment*genotype interaction whereby the reduction in liver fat will be significantly greater in GG relative to CC/CG subjects.
- Conditions
- NAFLD
- Being tested
- Standard of care plus sugar-reduction education
- Keywords
- obesity, fatty liver, sugar, PNPLA3
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care plus sugar-reduction educationOther
This is a 12-week intervention where subjects will be educated on how to monitor their added sugar consumption. They will be asked to eliminate consumption of sweetened beverages for the 12-week period and will be receiving a weekly delivery of water bottles to their homes to displace the sweetened beverages in their home environment.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Will receive standard of care, which is general dietary advice |
| Intervention Group | Experimental | Will receive standard of care as well as sugar-reduction education Receives: Other: Standard of care plus sugar-reduction education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total liver fat fraction by Magnetic resonance imaging (MRI) at baseline
Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.
Measured: Baseline
Total liver fat fraction by Magnetic resonance imaging (MRI) at 12 weeks
Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.
Measured: 12 weeks
Change in total liver fat fraction by Magnetic resonance imaging (MRI) from baseline to 12 weeks
Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.
Measured: Baseline and 12 weeks
Secondary outcomes (33)
Liver fibrosis by Magnetic Resonance Enterography (MRE) at baseline
MRE is a non-invasive technology for measuring tissue stiffness that has been validated against liver fibrosis by biopsy; as liver stiffness by MRE increases systematically with fibrosis stage. MRE can also discriminate between patients with moderate and severe fibrosis (grades 2-4) and those with mild fibrosis (sensitivity, 86%; specificity, 85%). MRE will be performed during the same scan for adipose tissue on the research-dedicated 3.0 Tesla GE Scanner equipped with the Mayo Clinic MRE apparatus, and synchronized motion-encoded GRE sequence, based on published validation studies.
Measured: Baseline
Liver fibrosis by Magnetic Resonance Enterography (MRE) at 12 weeks
MRE is a non-invasive technology for measuring tissue stiffness that has been validated against liver fibrosis by biopsy; as liver stiffness by MRE increases systematically with fibrosis stage. MRE can also discriminate between patients with moderate and severe fibrosis (grades 2-4) and those with mild fibrosis (sensitivity, 86%; specificity, 85%). MRE will be performed during the same scan for adipose tissue on the research-dedicated 3.0 Tesla GE Scanner equipped with the Mayo Clinic MRE apparatus, and synchronized motion-encoded GRE sequence, based on published validation studies.
Measured: 12 weeks
Change in Liver fibrosis by Magnetic Resonance Enterography (MRE) from baseline to 12 weeks
MRE is a non-invasive technology for measuring tissue stiffness that has been validated against liver fibrosis by biopsy; as liver stiffness by MRE increases systematically with fibrosis stage. MRE can also discriminate between patients with moderate and severe fibrosis (grades 2-4) and those with mild fibrosis (sensitivity, 86%; specificity, 85%). MRE will be performed during the same scan for adipose tissue on the research-dedicated 3.0 Tesla GE Scanner equipped with the Mayo Clinic MRE apparatus, and synchronized motion-encoded GRE sequence, based on published validation studies.
Measured: Baseline and 12 weeks
Total body fat, soft lean tissue, and bone mineral content by dual-energy x-ray absorptiometry (DXA) at baseline
Total body fat, soft lean tissue, and bone mineral content will be measured by dual energy x-ray absorptiometry (DXA) using a Hologic QDR 5400 densitometer (Hologic, Inc., Bedford, MA).
Measured: Baseline
Total body fat, soft lean tissue, and bone mineral content by dual-energy x-ray absorptiometry (DXA) at 12 weeks
Total body fat, soft lean tissue, and bone mineral content will be measured by dual energy x-ray absorptiometry (DXA) using a Hologic QDR 5400 densitometer (Hologic, Inc., Bedford, MA).
Measured: 12 weeks
Change in total body fat, soft lean tissue, and bone mineral content by dual-energy x-ray absorptiometry (DXA) from baseline to 12 weeks
Total body fat, soft lean tissue, and bone mineral content will be measured by dual energy x-ray absorptiometry (DXA) using a Hologic QDR 5400 densitometer (Hologic, Inc., Bedford, MA).
Measured: Baseline and 12 weeks
Liver enzymes by fasting blood analysis at baseline
A fasting blood sample will be taken at the baseline visit (during the OGTT) for determination of excessively elevated liver enzymes and risk of hereditary liver disease (ALT>300 IU).
Measured: Baseline
Liver enzymes by fasting blood analysis at 12 weeks
A fasting blood sample will be taken at 12 weeks (during the OGTT) for determination of excessively elevated liver enzymes and risk of hereditary liver disease (ALT>300 IU).
Measured: 12 weeks
Change in liver enzymes by fasting blood analysis from baseline to 12 weeks
A fasting blood sample will be taken at the baseline visit and 12 weeks (during the OGTT) for determination of excessively elevated liver enzymes and risk of hereditary liver disease (ALT>300 IU).
Measured: Baseline and 12 weeks
Fasting glucose at baseline
A fasting blood sample will be taken at the baseline visit (during the OGTT) for determination of elevated fasting glucose (>126 mg/dL) and risk of type 2 diabetes.
Measured: Baseline
Fasting glucose from 12 weeks
A fasting blood sample will be taken at the 12 week visit (during the OGTT) for determination of elevated fasting glucose (>126 mg/dL) and risk of type 2 diabetes.
Measured: 12 weeks
Change in fasting glucose from baseline to 12 weeks
A fasting blood sample will be taken at the baseline and 12 week visit (during the OGTT) for determination of elevated fasting glucose (>126 mg/dL) and risk of type 2 diabetes.
Measured: Baseline and 12 weeks
Insulin and glucose response to an oral glucose challenge at baseline
Glucose tolerance as well as insulin secretion and clearance will be determined during a standard 2-hour oral glucose tolerance test using a glucose load of 1.75g per kg of body weight to a maximum of 75g glucose dissolved in water. Samples will be drawn at 0, 15, 30, 60, 90 and 120 minutes and will be assayed for glucose, insulin, and C-peptide.
Measured: Baseline
Insulin and glucose response to an oral glucose challenge at 12 weeks
Glucose tolerance as well as insulin secretion and clearance will be determined during a standard 2-hour oral glucose tolerance test using a glucose load of 1.75g per kg of body weight to a maximum of 75g glucose dissolved in water. Samples will be drawn at 0, 15, 30, 60, 90 and 120 minutes and will be assayed for glucose, insulin, and C-peptide.
Measured: 12 weeks
Change in insulin and glucose response to an oral glucose challenge at baseline and 12 weeks
Glucose tolerance as well as insulin secretion and clearance will be determined during a standard 2-hour oral glucose tolerance test using a glucose load of 1.75g per kg of body weight to a maximum of 75g glucose dissolved in water. Samples will be drawn at 0, 15, 30, 60, 90 and 120 minutes and will be assayed for glucose, insulin, and C-peptide.
Measured: Baseline and 12 weeks
Lipids at baseline
The fasting blood sample will be assessed for lipid composition.
Measured: Baseline
Lipids at 12 weeks
The fasting blood sample will be assessed for lipid composition.
Measured: 12 weeks
Change in lipids from baseline to 12 weeks
The fasting blood sample will be assessed for lipid composition.
Measured: Baseline and 12 weeks
Adipokines at baseline
The fasting blood sample will be assessed for adipocytokines.
Measured: Baseline
Adipokines at 12 weeks
The fasting blood sample will be assessed for adipocytokines.
Measured: 12 weeks
Change in adipokines from baseline to 12 weeks
The fasting blood sample will be assessed for adipocytokines.
Measured: Baseline and 12 weeks
Inflammatory markers at baseline
The fasting blood sample will be assessed for inflammatory markers.
Measured: Baseline
Inflammatory markers at 12 weeks
The fasting blood sample will be assessed for inflammatory markers.
Measured: 12 weeks
Change in inflammatory markers from baseline to 12 weeks
The fasting blood sample will be assessed for inflammatory markers.
Measured: Baseline and 12 weeks
Hormones at baseline
The fasting blood sample will be assessed for hormones.
Measured: Baseline
Hormones 12 weeks
The fasting blood sample will be assessed for hormones.
Measured: 12 weeks
Change in hormones from baseline to 12 weeks
The fasting blood sample will be assessed for hormones.
Measured: Baseline and 12 weeks
Blood pressure at baseline
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes. Three readings of blood pressure will be obtained and the average of the two last readings will be recorded.
Measured: Baseline
Blood pressure at 12 weeks
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes. Three readings of blood pressure will be obtained and the average of the two last readings will be recorded.
Measured: 12 weeks
Change in blood pressure from baseline to 12 weeks
Sitting blood pressure will be measured on the right arm after the subject has rested quietly for 5 minutes. Three readings of blood pressure will be obtained and the average of the two last readings will be recorded.
Measured: Baseline and 12 weeks
Resting heart rate at baseline
Resting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes. Three readings of heart rate will be obtained and the average of the two last readings will be recorded.
Measured: Baseline
Resting heart rate at 12 weeks
Resting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes. Three readings of heart rate will be obtained and the average of the two last readings will be recorded.
Measured: 12 weeks
Change in resting heart rate from baseline to 12 weeks
Resting heart rate will be measured on the right arm after the subject has rested quietly for 5 minutes. Three readings of heart rate will be obtained and the average of the two last readings will be recorded.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2020
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Michael I. Goran, University of Southern California
- Investigators
- Michael I Goran, Principal investigator, University of Southern California; Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948647
- Sponsor's protocol ID
- HS-11-00446
- Acronym
- HEROES
- Status last verified
- Dec 2021
- First submitted
- 25 Oct 2016
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schenker RB, Ramirez CB, Jang C, Allayee H, Zhao X, Setchell KDR, Kohli R, Goran MI. Dihydroxyacetone phosphate is a novel predictor of hepatic fibrosis in Latino adolescents with obesity. J Pediatr Gastroenterol Nutr. 2025 Jan;80(1):174-181. doi: 10.1002/jpn3.12420. Epub 2024 Nov 25.
PubMed 39582475Schmidt KA, Jones RB, Rios C, Corona Y, Berger PK, Plows JF, Alderete TL, Fogel J, Hampson H, Hartiala JA, Cai Z, Allayee H, Nayak KS, Sinatra FR, Harlan G, Pickering TA, Salvy SJ, Mack WJ, Kohli R, Goran MI. Clinical Intervention to Reduce Dietary Sugar Does Not Affect Liver Fat in Latino Youth, Regardless of PNPLA3 Genotype: A Randomized Controlled Trial. J Nutr. 2022 Jul 6;152(7):1655-1665. doi: 10.1093/jn/nxac046.
PubMed 35218194
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diets Based on PNPLA3 Genotype for Reducing Liver Fat in Hispanics With Pediatric Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT02948647
- Acronym / sponsor ID
- HEROES / HS-11-00446
- Conditions
- NAFLD
- Keywords
- obesity, fatty liver, sugar, PNPLA3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Children's Hospital Los Angeles
- Study start
- Nov 2016 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 28 Oct 2016 (estimated)
- 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.
The purpose of the study is to determine the effect of dietary sugar reduction in obese children and examine whether there are differential effects based on genotype of a single amino acid substitution in the PNPLA3 gene that is highly prevalent in Hispanics and associated with significantly elevated liver fat.
Detailed description
This dietary intervention aims at developing a more personalized and targeted treatment for NAFLD in Hispanic children and adolescents who are GG for the PNPLA3 variant. The investigators previous publications have shown that this particular demographic has a greater than 2-fold higher liver fat compared to GC and CC individuals. They have also demonstrated a significant gene*dietary sugar interaction with a significant association between liver fat and dietary sugar intake in GG subjects with no such association in GC or CC individuals. These studies suggests that different dietary strategies may have differential effects on reducing liver fat, depending on PNPLA3 genotype. To confirm this, the investigators will complete a clinical trial in 120 overweight and obese Hispanic children (12 - 18 years) with clinically verified NAFLD who will be randomized to one of two 12-week interventions:
Group 1 (standard of care control group): Dietary intervention focused on healthy eating (n=60; 30GG + 30GC/CC)
Group 2 (standard of care + sugar reduction): Dietary intervention based on healthy eating and sugar reduction focused on reduction of sugary beverages and added sugar towards a goal of 10% of daily calories (n=60; 30GG + 30GC/CC)
The following outcomes will be measured before and after intervention: Total liver fat fraction, and visceral and subcutaneous abdominal adipose tissue volume by magnetic resonance imaging (MRI); liver fibrosis by magnetic resonance elastography (MRE); total body fat by DEXA; liver enzymes, fasting insulin, glucose, lipids, free fatty acids and inflammatory markers, gut microbiome, and insulin and glucose response to an oral glucose challenge. The investigators hypothesize that liver fat fraction, liver fibrosis, and metabolic outcomes, such as fasting and 2h-glucose and insulin, and inflammatory biomarkers, will show significantly greater improvements with sugar reduction relative to control. In addition, the investigators also hypothesize a treatment*genotype interaction whereby the reduction in liver fat will be significantly greater in GG relative to CC/CG subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Will receive standard of care, which is general dietary advice |
| Intervention Group | Experimental | Other: Standard of care plus sugar-reduction educationWill receive standard of care as well as sugar-reduction education |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Ethnicity: This study is limited to Hispanics because of their higher risk of NAFLD, higher frequency (~50%) of the at-risk PNPLA3 allele (G), and because no prior studies have targeted improvement in liver fat and NAFLD in this high-risk population. As with all of our ongoing studies, Hispanic ethnicity will be based on self-identity for the participants as well as their parents and grandparents.
- Gender: Males and females will be eligible for this study.
- Age: Children 12 to 18 years of age will be eligible. In our experience, children younger than around 10 years of age and greater than 18 years would require different intervention/counseling strategies. Therefore, we can develop a more consistent "age-neutral" approach if we limit the age range to 12-18 years.
- Weight status: Subjects will be eligible if they are obese, defined by a BMI > 95th percentile for age and gender.
Key exclusion criteria (9 listed)
- Diabetes: Presence of type 1 or 2 diabetes, as defined by fasting plasma glucose > 126 mg/dl, or positive for diabetes related antibodies including ICA512 and GAD. Participants testing positive for diabetes will be referred for treatment. Subjects with pre-diabetes will be eligible for the study
- Pregnancy: Women who self-report as pregnant or obtain a positive pregnancy test result during Visit 1 will be excluded. Furthermore, should a woman become pregnant during the course of the intervention, she will be withdrawn from the study at that time and asked to no longer participate. This is in order to protect the mother and child from radiation involved with the DEXA scan and potential complications associated with a low-sugar diet.
- Medication: Taking any medications known to influence liver function, insulin action or lipid levels
- Self-prescribed dietary supplements: Taking any non-prescription supplements that could potentially affect liver function and liver fat (eg vitamin E or fish oils)
- Other metabolic diseases: Diagnosis of other syndromes or diseases that may influence insulin action and secretion (e.g., maturity-onset diabetes of the young, lipoatrophic diabetes, cystic fibrosis), or body composition and fat distribution (e.g. Cushing syndrome, Down syndrome, lipodystrophy)
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 of care plus sugar-reduction educationThis is a 12-week intervention where subjects will be educated on how to monitor their added sugar consumption. They will be asked to eliminate consumption of sweetened beverages for the 12-week period and will be receiving a weekly delivery of water bottles to their homes to displace the sweetened beverages in their home environment. | Other | Intervention Group |
Primary outcome
Total liver fat fraction by Magnetic resonance imaging (MRI) at baseline
Time frame: Baseline
Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.
Total liver fat fraction by Magnetic resonance imaging (MRI) at 12 weeks
Time frame: 12 weeks
Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.
Change in total liver fat fraction by Magnetic resonance imaging (MRI) from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Abdominal fat distribution (visceral fat versus subcutaneous abdominal fat), and liver fat fraction will be assessed by magnetic resonance imaging at the USC Radiology imaging center on a research-dedicated GE 3 Tesla scanner. Visceral adipose tissue, subcutaneous abdominal adipose tissue and fat in the entire liver will be determined using the 3D IDEAL method.
33 secondary outcomes
Liver fibrosis by Magnetic Resonance Enterography (MRE) at baseline
Time frame: Baseline
Liver fibrosis by Magnetic Resonance Enterography (MRE) at 12 weeks
Time frame: 12 weeks
Change in Liver fibrosis by Magnetic Resonance Enterography (MRE) from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Total body fat, soft lean tissue, and bone mineral content by dual-energy x-ray absorptiometry (DXA) at baseline
Time frame: Baseline
Total body fat, soft lean tissue, and bone mineral content by dual-energy x-ray absorptiometry (DXA) at 12 weeks
Time frame: 12 weeks
Change in total body fat, soft lean tissue, and bone mineral content by dual-energy x-ray absorptiometry (DXA) from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Liver enzymes by fasting blood analysis at baseline
Time frame: Baseline
Liver enzymes by fasting blood analysis at 12 weeks
Time frame: 12 weeks
Change in liver enzymes by fasting blood analysis from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Fasting glucose at baseline
Time frame: Baseline
Fasting glucose from 12 weeks
Time frame: 12 weeks
Change in fasting glucose from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Insulin and glucose response to an oral glucose challenge at baseline
Time frame: Baseline
Insulin and glucose response to an oral glucose challenge at 12 weeks
Time frame: 12 weeks
Change in insulin and glucose response to an oral glucose challenge at baseline and 12 weeks
Time frame: Baseline and 12 weeks
Lipids at baseline
Time frame: Baseline
Lipids at 12 weeks
Time frame: 12 weeks
Change in lipids from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Adipokines at baseline
Time frame: Baseline
Adipokines at 12 weeks
Time frame: 12 weeks
Change in adipokines from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Inflammatory markers at baseline
Time frame: Baseline
Inflammatory markers at 12 weeks
Time frame: 12 weeks
Change in inflammatory markers from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Hormones at baseline
Time frame: Baseline
Hormones 12 weeks
Time frame: 12 weeks
Change in hormones from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Blood pressure at baseline
Time frame: Baseline
Blood pressure at 12 weeks
Time frame: 12 weeks
Change in blood pressure from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Resting heart rate at baseline
Time frame: Baseline
Resting heart rate at 12 weeks
Time frame: 12 weeks
Change in resting heart rate from baseline to 12 weeks
Time frame: Baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Derived from this study: PubMed 39582475Schenker RB, Ramirez CB, Jang C, Allayee H, Zhao X, Setchell KDR, Kohli R, Goran MI. Dihydroxyacetone phosphate is a novel predictor of hepatic fibrosis in Latino adolescents with obesity. J Pediatr Gastroenterol Nutr. 2025 Jan;80(1):174-181. doi: 10.1002/jpn3.12420. Epub 2024 Nov 25.
- Derived from this study: PubMed 35218194Schmidt KA, Jones RB, Rios C, Corona Y, Berger PK, Plows JF, Alderete TL, Fogel J, Hampson H, Hartiala JA, Cai Z, Allayee H, Nayak KS, Sinatra FR, Harlan G, Pickering TA, Salvy SJ, Mack WJ, Kohli R, Goran MI. Clinical Intervention to Reduce Dietary Sugar Does Not Affect Liver Fat in Latino Youth, Regardless of PNPLA3 Genotype: A Randomized Controlled Trial. J Nutr. 2022 Jul 6;152(7):1655-1665. doi: 10.1093/jn/nxac046.
- 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. This study is not recruiting at the moment.
Michael I Goran principal investigator
University of Southern California; Children's Hospital Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of NAFLD, run by University of Southern California at 2 sites 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total liver fat fraction by Magnetic resonance imaging (MRI) at baseline (time frame: Baseline). The study lists 3 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 NCT02948647, which also lists 2 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 9 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.