Dietary Interventions for Fatty Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find the best way to treat fatty liver disease in children using either a special mix of essential amino acids (a type of supplement) or a diet low in sugar. Both treatments have shown promise in reducing liver fat build-up. The trial seeks children aged 11 to 17 with fatty liver disease, a high body mass index (BMI), and high consumption of sugary drinks. Participants must be open to trying new diets or supplements. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Do I need to stop my current medications for the trial?
The trial requires that if you are taking medications that affect insulin, like metformin or corticosteroids, you must be on a stable dosage for at least 3 months before joining. Other medications are not specifically mentioned, so it's best to discuss with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that essential amino acid (EAA) supplements are generally safe and may improve liver health. Studies have found that EAA supplements can lower liver fat and boost protein production. Specifically, research involving older adults and animals demonstrated positive effects on liver function with few side effects. However, despite these encouraging results, EAA supplements are not yet commonly recommended for liver issues due to varying study outcomes.
Regarding a low sugar diet, studies have found it safe and effective in reducing liver fat. In one study, children and teenagers who followed a low sugar diet had less liver fat after eight weeks. This diet is often part of healthy lifestyle changes suggested for managing liver health, with no major negative effects reported.
Both treatments appear well-tolerated with few safety concerns, making them promising options for improving liver health in children with fatty liver disease.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for fatty liver disease because they offer unique approaches compared to standard options like lifestyle changes and medications. The Essential Amino Acids Supplementation stands out by potentially decreasing liver fat and harmful blood fats through novel mechanisms, such as boosting fat breakdown and improving how the liver handles triglycerides. Meanwhile, the Low Sugar Diet is distinctive for using a targeted approach to eliminate high-sugar foods, guided by expert dietitians, potentially making it easier for families to maintain long-term dietary changes. These innovative strategies could provide new, effective ways to combat fatty liver disease.
What evidence suggests that this trial's treatments could be effective for metabolic dysfunction associated steatotic liver disease?
This trial will compare the effectiveness of two dietary interventions for fatty liver disease: Essential Amino Acids Supplementation and a Low Sugar Diet. Studies have shown that essential amino acids (EAAs) effectively reduce liver fat in teenagers and improve liver health by lowering harmful liver enzymes and fats in the blood. Research also shows that a low sugar diet can significantly reduce liver fat, with one study reporting an average reduction of 31% in boys with fatty liver disease. Both treatments work by either boosting metabolism or reducing sugar intake, which helps lower liver fat and improve liver health. These findings suggest that these methods could be promising for treating fatty liver disease in children.16789
Who Is on the Research Team?
Miriam B Vos, MD, MSPH
Principal Investigator
Michigan State University
Are You a Good Fit for This Trial?
This trial is for children aged 11-17 with fatty liver disease (MASLD), who are overweight or have other heart/metabolic risk factors, and show at least 8% liver fat on MRI. They must not have advanced liver disease, diabetes, certain other illnesses, or be pregnant/breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Essential Amino Acids Supplementation or Low Sugar Diet intervention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Essential Amino Acids Supplementation intervention
- Low sugar diet
Trial Overview
The study tests if essential amino acid supplements and/or a low sugar diet can help improve fatty liver in kids. Participants are randomly assigned to different groups using an adaptive design to find the best approach.
How Is the Trial Designed?
2
Treatment groups
Active Control
The essential amino acid supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine. EAA, also called AMS2392 has been shown to decrease hepatic steatosis and lower circulating very-low-density lipoprotein triglyceride (VLDL-TG) concentrations through one or more of the following mechanisms: decreasing de novo lipogenesis; increasing hepatic and systemic fatty acid oxidation; increasing triglyceride secretion from the liver in the form of VLDL-TG; and increasing clearance of circulating VLDL-TG via activation of lipoprotein lipase.
The Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention that the Emory team previously developed. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Michigan State University
Lead Sponsor
Corewell Health West
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Van Andel Research Institute
Collaborator
Emory University
Collaborator
The Amino Company
Collaborator
Citations
Essential Amino Acid Supplement Lowers Intrahepatic Lipid ...
We have previously demonstrated that an essential amino acid supplement (EAAS) improved protein synthesis and reduced intrahepatic lipid in the elderly.
Metabolic effects of an essential amino acid supplement in ...
Similar to studies in older adults, short-term EAA supplementation in adolescents resulted in significantly lower liver fat, AST, and plasma ...
Metabolic effects of an essential amino acid supplement in ...
Short-term EAA supplementation in adolescents resulted in significantly lower liver fat, AST, and plasma lipids and thus may prove to be an effective treatment ...
Amelioration of hepatic steatosis by dietary essential amino ...
In this study, we found that dietary essential amino acids ameliorate hepatic steatosis by inducing polyubiquitination and proteasomal degradation of Plin2.
Amelioration of hepatic steatosis by dietary essential amino ...
Dietary BCAA supplementation has emerged as a promising therapeutic approach for NAFLD (Hamill et al., 2020; Marchesini et al., 2003). Among ...
Effects of supplementation with essential amino acids on ...
The aim of this study was to evaluate the effect of essential amino acid supplementation on the increase in hepatic fat content induced by a high-fructose diet ...
The association between dietary consumption of amino acids ...
We also found that dietary non-essential amino acids may provide beneficial effects against NAFLD in females. However, such associations were ...
Amelioration of hepatic steatosis by dietary essential amino ...
We further show that the amino acid-induced Ubr1 activity is necessary to prevent steatosis in mouse livers and cultured human hepatocytes, ...
Amino Acids for Fatty Liver Disease (AMINOS Trial)
This trial tests whether the Essential Amino Acid Supplement by Amino Co can reduce liver fat in teens with non-alcoholic fatty liver disease (NAFLD).
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