Carbohydrate-Restricted Diet for Non-alcoholic Fatty Liver Disease
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used medications known to induce steatosis, elevate liver enzymes, or affect body weight and carbohydrate metabolism in the last 6 months.
What data supports the effectiveness of a carbohydrate-restricted diet as a treatment for non-alcoholic fatty liver disease?
Research suggests that low carbohydrate diets can help reduce liver fat content and improve metabolic issues related to non-alcoholic fatty liver disease (NAFLD). Studies have shown that both low carbohydrate and moderate carbohydrate diets can be effective in managing NAFLD, especially when combined with weight loss.12345
Is a carbohydrate-restricted diet safe for humans?
Research suggests that carbohydrate-restricted diets can be safe for humans, as they have been shown to decrease liver fat content and improve metabolic conditions in people with non-alcoholic fatty liver disease. However, diets high in saturated fats can increase liver fat and insulin resistance, so it's important to consider the type of fats consumed.12346
How does a moderately carbohydrate-restricted diet differ from other treatments for non-alcoholic fatty liver disease?
A moderately carbohydrate-restricted diet is unique because it focuses on reducing carbohydrate intake without necessarily restricting calories or fats, which can improve liver fat content and metabolic health. This approach is different from traditional low-calorie diets that often have poor adherence due to their restrictive nature.12347
What is the purpose of this trial?
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.
Eligibility Criteria
This trial is for children and adolescents aged 10-17 with Non-alcoholic Fatty Liver Disease (NAFLD) who are overweight or obese. They must have evidence of fatty liver via ultrasound, elevated ALT levels, and an HbA1c below 7%. Participants should not be on certain medications affecting the liver, be pregnant, or have other specific liver diseases.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Controlled feeding phase
Participants receive all food via home delivery for 12 weeks, with weekly monitoring and dietitian meetings
Free living phase
Participants continue their assigned diet without provided groceries, with self-monitoring and dietitian support
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Fat-restricted diet
- Moderately carbohydrate-restricted diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alabama at Birmingham
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator