What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include dietary interventions, such as reducing sugar intake, which generally have minimal side effects but may cause initial gastrointestinal discomfort. Pharmacologic treatments like metformin can lead to gastrointestinal issues such as nausea, diarrhea, and abdominal discomfort. Obeticholic acid, another treatment option, has been associated with pruritus (itching) and elevated cholesterol levels. Lifestyle changes, including exercise, are also recommended and typically result in positive side effects like improved cardiovascular health and weight loss.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved drugs for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). However, lifestyle modifications, including dietary changes to reduce sugar intake, are commonly recommended to manage and prevent NAFLD. Some studies have shown that lipid-lowering agents and medications like metformin, which improve metabolic function, can be beneficial in reducing liver fat and inflammation. Additionally, drugs like obeticholic acid have shown promise in clinical trials for improving hepatic fibrosis in NAFLD patients.

What other types of research exist?

Promising novel alternatives to dietary sugar reduction for NAFLD patients include: 1) Medications such as GLP-1 receptor agonists (e.g., liraglutide) and SGLT2 inhibitors, which have shown efficacy in improving liver histology and reducing liver fat. 2) Lifestyle modifications, including increased physical activity and adherence to a Mediterranean diet, which have been associated with reduced liver fat and inflammation. 3) Emerging therapies from recent clinical trials targeting NASH resolution, such as drugs that modulate lipid metabolism, inflammation, and fibrosis.

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Behavioral Intervention

LFSD for Preventing Fatty Liver Disease in Children

N/A

Recruiting

Led By Miriam Vos, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BMI ≥ 50th percentile for age and sex

Tanner stage 1 by self and/or parental report

Must not have

History of significant depression

Recipient of a liver transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 6, month 12, month 18 and month 24

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if reducing sugar intake can prevent liver disease in overweight Hispanic children aged 6-9. Eating less sugar helps reduce liver fat, improving health and lowering disease risk.

Who is the study for?

This trial is for pre-pubertal Hispanic children aged 6-9 with a BMI ≥ 50th percentile, normal liver enzymes, and no significant health issues like cancer or chronic liver diseases other than NAFLD. They must not be on certain medications, planning to move soon, or have conditions that prevent MRI scans.

What is being tested?

The study tests an intensive diet intervention focused on reducing dietary sugars to prevent non-alcoholic fatty liver disease (NAFLD) in children. It's a two-year trial where the effectiveness of this Low Free Sugar Diet (LFSD) will be monitored.

What are the potential side effects?

Since the intervention involves dietary changes rather than medication, side effects may include changes in bowel habits or food cravings. However, serious side effects are unlikely with diet modification.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is in the top 50% for my age and gender.

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My physical development is at the earliest puberty stage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of severe depression.

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I have received a liver transplant.

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I have a chronic liver condition that is not NAFLD or 'fatty liver'.

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I have type 2 diabetes with an A1c over 6.4%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 6, month 12, month 18 and month 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 6, month 12, month 18 and month 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6, month 12, month 18 and month 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Percent Hepatic Steatosis by MRI-PDFF

Onset of NAFLD

Secondary study objectives

Changes Oral Glucose tolerance test (OGTT)

Changes in BMI

Changes in Fasting insulin

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Low Free Sugar Diet (LFSD) InterventionExperimental Treatment1 Intervention

The 1-year dietary intervention will be accomplished by adapting and extending a Social Cognitive Theory (SCT) guided low sugar intervention. SCT is a framework that helps explain how people regulate their behavior through control and reinforcement to achieve goal-directed behavior that can be maintained over time.

Group II: Usual Care ControlActive Control1 Intervention

Usual Care (Control group): Parents of enrolled children in the usual care group will be provided printed material on healthy family lifestyle at the beginning of the study. The control group will complete all of the same research visits and assessments as the intervention group.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include dietary interventions, exercise, and certain medications. Reducing dietary sugars is a primary strategy, as it decreases the metabolic burden on the liver, preventing fat accumulation and inflammation. Exercise also plays a crucial role by improving insulin sensitivity and promoting weight loss, which further reduces liver fat. Medications like pioglitazone and GLP-1 receptor agonists improve insulin resistance and have anti-inflammatory effects. These treatments are essential for NAFLD patients as they address the underlying metabolic dysfunction, thereby preventing disease progression and improving liver health.