Moderately carbohydrate-restricted diet for treating fatty liver disease in adolescents
Moderately Carbohydrate-restricted Diet as Treatment Targeting Improvement in Hepatic Lipid and Insulin Sensitivity in Adolescents With NAFLD
This study is testing if a diet with fewer carbs can help overweight teens with fatty liver disease improve their liver health over six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 10 Years to 17 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT05268042 on ClinicalTrials.gov |
What this trial studies
This clinical trial involves a 6-month randomized approach comparing a moderately carbohydrate-restricted diet to a fat-restricted control diet in adolescents diagnosed with Non-Alcoholic Fatty Liver Disease (NAFLD). The study consists of two phases: a 12-week controlled feeding phase where all meals are provided, followed by a 12-week 'free living' phase. Participants will be children and adolescents aged 10-17 years who are overweight or obese, with specific criteria for liver health. The goal is to assess the impact of dietary changes on liver health and insulin sensitivity.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 10-17 years who are overweight or obese and have a clinical diagnosis of NAFLD.
Not a fit: Patients with uncontrolled diabetes, liver infections, or those on medications affecting liver health may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved liver health and metabolic outcomes for adolescents with NAFLD.
How similar studies have performed: Previous studies have shown that carbohydrate-restricted diets can improve liver health and insulin sensitivity in similar populations, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * clinical-pathological diagnosis of NAFLD and current evidence of active disease, which will be determined by the ongoing presence of hepatic steatosis estimated by diffusely echogenic liver via ultrasound suggestive of fatty liver and a serum alanine aminotransferase (ALT) level of 45 U/L or greater. * age 10 -17 yrs * overweight or obese (BMI \>75th percentile). Exclusion Criteria: * pregnancy * HbA1c \>7% * history of parenteral nutrition * hepatic virus infections (HCV RNA-polymerase chain reaction negative; hepatitis A, B, C, D, E, and G; cytomegalovirus; and Epstein-Barr virus) * use of medications known to induce steatosis (e.g. valproate, amiodarone, or prednisone), elevate liver enzymes, or affect body weight and carbohydrate metabolism (within the last 6months) * autoimmune liver disease * metabolic liver disease * Wilson's disease * genetic conditions (e.g. glycogen storage disorder) leading to hepatic steatosis; * history of bariatric surgery * participants and parents/guardians unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures * inability to speak and comprehend English (participants and parents/guardians) * currently receiving intense lifestyle modification treatment * estimated Glomerular Filtration Rate (eGFR) \<60 * alcohol, tobacco or recreational drug use * unable to undergo MRI.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Study coordinator: Alex Luzuriaga-McPherson
- Email: alexandramcpherson@uabmc.edu
- Phone: 205-934-6299
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.