Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents

Completed · Not applicable

Conditions studied: Non-Alcoholic Fatty Liver Disease, Obesity

In brief

This will be a 6-month randomized clinical trial with two arms: moderately carbohydrate-restricted diet and a fat-restricted control diet. This 6-month study will have 2 phases: a 12-week controlled feeding phase and a 12-week "free living" phase. During the controlled feeding phase, all food will be provided to the families of the participants for the entirety of the 12 weeks. Participants (n=80) will have been diagnosed with NAFLD based on the presence of 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. All participants will be children and adolescents age 10-17 yrs.; will have an HbA1c \<7.0; and will be overweight or obese (BMI \>85th percentile). It is anticipated that most participants will be sedentary. The investigators will inquire as to routine physical activity at screening. All participants will be asked to maintain their usual level of physical activity throughout the study. Physical activity will be monitored via a smart watch provided to each participant at the beginning of the study, and participants will be queried weekly by the study dietitian regarding changes in physical activity. Participants who use oral contraceptives will be asked to maintain consistent use of these preparations throughout the study. Hormone use will be examined as a potential covariate in statistical analyses.

Key facts

Study ID

NCT05268042

Run by

University of Alabama at Birmingham

People needed

50

Starts

2022-05-01

Expected to finish

2026-07-21

Last updated by the study team

2026-07-27

Who can join

Age: 10 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• age 10 -17 yrs
• overweight or obese (BMI >75th percentile).

You may not qualify if…

• 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
• currently receiving intense lifestyle modification treatment
• estimated Glomerular Filtration Rate (eGFR) <60
• alcohol, tobacco or recreational drug use
• unable to undergo MRI.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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