Carbohydrate-Restricted Diet for Non-alcoholic Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama at Birmingham
Must not be taking: Valproate, Amiodarone, Prednisone, others
Disqualifiers: Pregnancy, Hepatic virus infections, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
12346How 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.
12347Eligibility 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
Overweight or obese (BMI >75th percentile)
I am between 10 and 17 years old.
I have been diagnosed with fatty liver disease and my liver tests are high.
Exclusion Criteria
I am currently undergoing a strict lifestyle change program.
I am willing and able to follow the study's requirements.
I haven't taken drugs that affect liver fat, enzymes, weight, or sugar levels in the last 6 months.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Controlled feeding phase
Participants receive all food via home delivery for 12 weeks, with weekly monitoring and dietitian meetings
12 weeks
12 visits (in-person or virtual)
Free living phase
Participants continue their assigned diet without provided groceries, with self-monitoring and dietitian support
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study compares a moderately carbohydrate-restricted diet to a fat-restricted diet over six months. It includes a controlled feeding phase where food is provided for 12 weeks followed by a 'free living' phase. Physical activity will be monitored using smart watches.
2Treatment groups
Experimental Treatment
Active Control
Group I: Moderately carbohydrate-restricted dietExperimental Treatment1 Intervention
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.
Group II: Fat-restricted dietActive Control1 Intervention
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).
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Alabama at BirminghamBirmingham, AL
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Who Is Running the Clinical Trial?
University of Alabama at BirminghamLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Adherence to low carbohydrate diets and non-alcoholic fatty liver disease: a case control study. [2023]Non-alcoholic fatty liver disease (NAFLD) is defined as the excessive accumulation of fat in the liver cells of people who do not drink alcohol. The aim of study is investigated the association between low carbohydrate diets (LCDs) and NAFLD.
Moderate-carbohydrate diet without caloric or lipid restriction for Japanese adult patients with nonalcoholic fatty liver disease: A prospective cohort study. [2023]Although a low-calorie diet with lipid restriction is recommended in clinical practice guidelines for nonalcoholic fatty liver disease (NAFLD), both compliance and adherence are poor. The present study aimed to evaluate the compliance, adherence, and effectiveness of a moderate-carbohydrate diet without caloric or lipid restrictions.
Nutritional Modulation of Non-Alcoholic Fatty Liver Disease and Insulin Resistance. [2018]Non-alcoholic fatty liver disease (NAFLD) covers a spectrum of disorders ranging from simple steatosis (non-alcoholic fatty liver, NAFL) to non-alcoholic steatohepatitis (NASH) and cirrhosis. NAFL increases the risk of liver fibrosis. If the liver is fatty due to causes of insulin resistance such as obesity and physical inactivity, it overproduces glucose and triglycerides leading to hyperinsulinemia and a low high-density lipoprotein (HDL) cholesterol concentration. The latter features predispose to type 2 diabetes and cardiovascular disease (CVD). Understanding the impact of nutritional modulation of liver fat content and insulin resistance is therefore of interest for prevention and treatment of NAFLD. Hypocaloric, especially low carbohydrate ketogenic diets rapidly decrease liver fat content and associated metabolic abnormalities. However, any type of caloric restriction seems effective long-term. Isocaloric diets containing 16%-23% fat and 57%-65% carbohydrate lower liver fat compared to diets with 43%-55% fat and 27%-38% carbohydrate. Diets rich in saturated (SFA) as compared to monounsaturated (MUFA) or polyunsaturated (PUFA) fatty acids appear particularly harmful as they increase both liver fat and insulin resistance. Overfeeding either saturated fat or carbohydrate increases liver fat content. Vitamin E supplementation decreases liver fat content as well as fibrosis but has no effect on features of insulin resistance.
Effect of a moderately carbohydrate-restricted diet on liver enzymes, steatosis and fibrosis in normal-weight individuals with non-alcoholic fatty liver disease: study protocol for a parallel randomised controlled clinical trial. [2023]Non-alcoholic fatty liver disease (NAFLD) is a hepatic condition that is considerably prevalent across the world. Dietary intakes, in which macronutrient composition is precisely planned, might be able to reduce inflammation, steatosis and fibrosis among patients with NAFLD. A moderately carbohydrate restricted diet with weight loss has been demonstrated to improve liver fat content among overweight or obese patients. However, there is no information about the appropriateness of such a restriction, without weight loss, in normal-weight patients. This randomised clinical trial will be aimed at assessing the effect of moderate carbohydrate restriction on liver enzymes, liver steatosis and fibrosis in normal-weight patients with NAFLD.
Eating, diet, and nutrition for the treatment of non-alcoholic fatty liver disease. [2023]Nutrition and dietary interventions are a central component in the pathophysiology, but also a cornerstone in the management of patients with non-alcoholic fatty liver disease (NAFLD). Summarizing our rapidly advancing understanding of how our diet influences our metabolism and focusing on specific effects on the liver, we provide a comprehensive overview of dietary concepts to counteract the increasing burden of NAFLD. Specifically, we emphasize the importance of dietary calorie restriction independently of the macronutrient composition together with adherence to a Mediterranean diet low in added fructose and processed meat that seems to exert favorable effects beyond calorie restriction. Also, we discuss intermittent fasting as a type of diet specifically tailored to decrease liver fat content and increase ketogenesis, awaiting future study results in NAFLD. Finally, personalized dietary recommendations could be powerful tools to increase the effectiveness of dietary interventions in patients with NAFLD considering the genetic background and the microbiome, among others.
Comparison of efficacy of low-carbohydrate and low-fat diet education programs in non-alcoholic fatty liver disease: A randomized controlled study. [2020]Composition of macronutrients is important in non-alcoholic fatty liver disease (NAFLD). Diet education programs that mainly emphasize reducing fat consumption have been used for NAFLD patients. We compared the efficacy of conventional low-fat diet education with low-carbohydrate diet education in Korean NAFLD patients.
The effect of a low-carbohydrate, ketogenic diet on nonalcoholic fatty liver disease: a pilot study. [2018]Nonalcoholic fatty liver disease is an increasingly common condition that may progress to hepatic cirrhosis. This pilot study evaluated the effects of a low-carbohydrate, ketogenic diet on obesity-associated fatty liver disease. Five patients with a mean body mass index of 36.4 kg/m(2) and biopsy evidence of fatty liver disease were instructed to follow the diet (