102 Participants NeededMy employer runs this trial

Dietary Interventions for Fatty Liver Disease

YE
MB
Overseen ByMiriam B Vos, MD, MSPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

MB

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

I am between 11 and 17 years old.
I have at least one risk factor like high BMI, blood pressure, cholesterol, or signs of prediabetes.
Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI
See 5 more

Exclusion Criteria

Albumin less than 3.2 g/dL
Current participation in another clinical trial
Elevated total bilirubin except if known to have Gilbert's syndrome and direct bilirubin in normal range
See 15 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Essential Amino Acids Supplementation or Low Sugar Diet intervention

24 weeks
Regular visits at baseline, 12 weeks, and 24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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

Group I: Essential Amino Acids SupplementationActive Control1 Intervention
Group II: Low Sugar DietActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials
202
Recruited
687,000+

Corewell Health West

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Van Andel Research Institute

Collaborator

Trials
28
Recruited
5,200+

Emory University

Collaborator

Trials
1,735
Recruited
2,605,000+

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 ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38439205/

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).