Preventing liver disease in Hispanic children through a low sugar diet

Prevention of Non-alcoholic Fatty Liver Disease (NAFLD) in Hispanic Children

This study is testing if a very low sugar diet can help prevent liver disease in Hispanic children aged 6 to 9 who are at risk due to obesity.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 6 Years to 9 Years
• Sex: All
• Sponsor: Emory University (Academic / other)
• Locations: 1 site (Atlanta, Georgia)
• Trial ID: NCT05292352 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to test an intensive intervention that reduces dietary sugars to prevent non-alcoholic fatty liver disease (NAFLD) in pre-pubertal Hispanic children. Over a two-year period, the study will focus on children aged 6 to 9 years who are at high risk for NAFLD due to obesity. Participants will follow a very low free sugar diet, with the goal of reducing fat accumulation in the liver and improving overall metabolic health. The trial will be conducted at a single site in Atlanta, utilizing local pediatric clinics for recruitment.

Who should consider this trial

Good fit: Ideal candidates for this study are Hispanic children aged 6 to 9 years who are overweight or obese and in Tanner stage 1.

Not a fit: Patients with known chronic liver disease, significant depression, or type 2 diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce the incidence of NAFLD in high-risk Hispanic children, leading to better long-term health outcomes.

How similar studies have performed: Previous studies have shown that reducing sugar intake can improve liver health in children, suggesting a promising approach for this population.

Eligibility criteria

Inclusion Criteria:

1. At least one parent or the child self-identifies as Hispanic or Latino.
2. BMI ≥ 50th percentile for age and sex.
3. Age ≥ 6 years and ≤ 9 years
4. Tanner stage 1 by self and/or parental report
5. Normal ALT on screening labs (≤23 IU for girls, ≤26 IU for boys)
6. Written informed consent from parent or legal guardian, assent from child

Exclusion Criteria:

1. Known diagnosis of chronic liver disease other than NAFLD and "fatty liver"
2. History of significant depression
3. Implanted metal or other implant (braces ok), or claustrophobia or other reason that contraindicates MRI
4. Type 2 diabetes (Hemoglobin A1c \> 6.4% on screening labs or chronic diagnosis)
5. Plans to move within the next 12 months
6. Current or previous participation in a weight loss program or obesity treatment program or clinic
7. Cancer or history of cancer
8. Recipient of a liver transplant
9. Chronic use (in the last year) of medications known to cause NAFLD or fatty liver (TPN, amiodarone, chronic oral steroids, etc.)
10. Intellectual disability or major psychiatric disorder limiting informed assent
11. At risk for eating disorder by screening instrument
12. Participants who are currently enrolled in a clinical trial or have received an investigational product within the last 60 days
13. Participants who are not able or willing to comply with the diet protocol or have any other condition or circumstance that would impede compliance or hinder completion of the study in the opinion of the investigator
14. Children who spend more than 1 night per week consistently in another household

Where this trial is running

Atlanta, Georgia

• Emory University — Atlanta, Georgia, United States (Recruiting)

Study contacts

• Principal investigator: Miriam Vos, MD — Emory University
• Study coordinator: Miriam Vos, MD

Conditions Non-Alcoholic Fatty Liver Disease; Latino Children; Pre-puberal; Low Free sugar diet