Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents

Launched by UNIVERSITY OF ALABAMA AT BIRMINGHAM · Feb 24, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different diets on adolescents with Non-Alcoholic Fatty Liver Disease (NAFLD), a condition where fat builds up in the liver without alcohol consumption. The trial will last for 6 months and involves 80 participants aged 10 to 17 years who are overweight or obese. Participants will be randomly assigned to either a moderately carbohydrate-restricted diet or a fat-restricted control diet. During the first 12 weeks, all meals will be provided to the families, and in the following 12 weeks, participants will eat at home while continuing to follow their assigned diet.

To be eligible for this study, participants must have a confirmed diagnosis of NAFLD and meet certain health criteria, such as having a body mass index (BMI) above the 75th percentile. They should also maintain their usual level of physical activity, which will be monitored with a smartwatch. The study team will guide and support participants throughout the trial, ensuring they have the resources and information they need to adhere to the diet and participate fully. Overall, this trial aims to find out which diet might be more effective in helping manage NAFLD in adolescents.

Gender

ALL

Eligibility 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.