An interventional study of Standard of care plus sugar-reduction education in NAFLD, sponsored by University of Southern California. Completed at 2 sites in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2021-12-09.
Sponsored by University of Southern California · Not applicable, Interventional, and Treatment
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.
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.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's enrollment of 113 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
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Of its 68 completed or terminated interventional studies of FDA-regulated products, 32 (47%) have results posted.
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Exclusion Criteria:
Will receive standard of care, which is general dietary advice
Will receive standard of care as well as sugar-reduction education
Other: Standard of care plus sugar-reduction education
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
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.
Time frame: 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.
Time frame: 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.
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
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).
Time frame: 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).
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
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Lipids at baseline
The fasting blood sample will be assessed for lipid composition.
Time frame: Baseline
Lipids at 12 weeks
The fasting blood sample will be assessed for lipid composition.
Time frame: 12 weeks
Change in lipids from baseline to 12 weeks
The fasting blood sample will be assessed for lipid composition.
Time frame: Baseline and 12 weeks
Adipokines at baseline
The fasting blood sample will be assessed for adipocytokines.
Time frame: Baseline
Adipokines at 12 weeks
The fasting blood sample will be assessed for adipocytokines.
Time frame: 12 weeks
Change in adipokines from baseline to 12 weeks
The fasting blood sample will be assessed for adipocytokines.
Time frame: Baseline and 12 weeks
Inflammatory markers at baseline
The fasting blood sample will be assessed for inflammatory markers.
Time frame: Baseline
Inflammatory markers at 12 weeks
The fasting blood sample will be assessed for inflammatory markers.
Time frame: 12 weeks
Change in inflammatory markers from baseline to 12 weeks
The fasting blood sample will be assessed for inflammatory markers.
Time frame: Baseline and 12 weeks
Hormones at baseline
The fasting blood sample will be assessed for hormones.
Time frame: Baseline
Hormones 12 weeks
The fasting blood sample will be assessed for hormones.
Time frame: 12 weeks
Change in hormones from baseline to 12 weeks
The fasting blood sample will be assessed for hormones.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 12 weeks
Plan to share: No
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