Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents
Non-Alcoholic Fatty Liver Disease, Obesity
About this trial
This is an interventional treatment trial for Non-Alcoholic Fatty Liver Disease focused on measuring NAFLD, Obesity, Insulin sensitivity
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 12-17 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.
Sites / Locations
- University of Alabama at BirminghamRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Moderately carbohydrate-restricted diet
Fat-restricted diet
For this study, the investigators will use the low glycemic, moderately carbohydrate-restricted diet that the investigators have previously shown is associated with depletion of hepatic lipid content, and improvement in insulin resistance in adolescents with NAFLD. This diet has a macronutrient composition of approximately 25% energy from carbohydrate, 20% energy from protein, and 55% energy from fat. No food group is excluded in this diet prescription; however, the diet emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary. Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included.
The fat-restricted, control diet will consist of approximately 60% carbohydrate, 20% protein, 20% fat. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to 10% of total fat intake, and all dairy products will be fat-free (or low fat).