Non-Alcoholic Fatty Liver DiseaseNCT05268042
Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents
A study testing Moderately carbohydrate-restricted diet and Fat-restricted diet in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Obesity
- What is being tested?
- Moderately carbohydrate-restricted diet and Fat-restricted diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2022to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35226
About this study
Official title: Moderately Carbohydrate-restricted Diet as Treatment Targeting Improvement in Hepatic Lipid and Insulin Sensitivity in Adolescents With NAFLD
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.
Read the detailed description
Under energy balance conditions when carbohydrates are restricted, protein or fat will increase. Large increases in dietary protein are undesirable due to the potential stimulation of hepatic gluconeogenesis. If dietary fat is increased, attention should be paid to the quality or composition of this fat. In order to minimize differences in the quality and composition of fats included in both diets, consumption of similar proportions and sources of saturated, mono-and polyunsaturated fats will be emphasized. Increased intake of polyunsaturated fats (ω-3 and ω-6) have been shown to decrease hepatic inflammation, improve hepatic function, and inhibit de novo lipogenesis; thus, diets will provide a 4:1 ratio of poly- to monounsaturated fatty acids. Because the carbohydrate-restricted diet will limit total grams of carbohydrate, total fat will increase thereby increasing the amount of dietary cholesterol provided by the diet, which may be unavoidable. However, the diet prescriptions will be matched for and provide adequate sodium intake.
carbohydrate-restricted diet. For this study, the investigators will use the low glycemic, 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. The investigators have successfully incorporated a limited number of "convenience" foods in our carbohydrate-restricted diet.. Incorporation of these foods increases the ultimate translatability of the carbohydrate-restricted diet, and the likelihood that participants can and will continue with the diet on their own initiative. Thus, the investigators will include some convenience foods in this study, as appropriate for the individual participant's needs. 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. These products provide specific fatty acids that will be used to assess adherence. Saturated fat will be limited to less than 10% of daily total fat intake. Patients will obtain the majority of their fat intake from poly- and mono-unsaturated fatty acids at a 4:1 ratio (from nuts, nut butters, and from fresh fish), and saturated fat will be primarily derived from medium-chain triglycerides (e.g., coconut oil and cream), some meat, and dairy.
Fat-restricted diet. 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 less than 10% of total fat intake, and all dairy products will be fat-free (or low fat). Patients will obtain the majority of their fat intake from poly- and mono-unsaturated fatty acids at a 4:1 ratio matched to the carbohydrate-restricted group; however, total grams will be lower. Although the fat-restricted diet will be a high quality, healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the carbohydrate-restricted diet. In addition, it will have a higher glycemic load than the carbohydrate-restricted diet. Thus, the greater glycemic load of the fat-restricted diet will derive from both inclusion of foods with a higher glycemic index and incorporation of a greater proportion of total energy from carbohydrates.
Controlled feeding phase (Phase 1) During the first 12-weeks, all food will be provided to participants. Participants will receive their weekly groceries via home delivery from a grocery store via a grocery delivery service. The study dietitian will order all groceries on-line, and the groceries will be delivered to the participants at their selected time and date. In cases where the participant's family lives outside of delivery zones, the food will be delivered to University of Alabama at Birmingham (UAB) (the Department of Nutrition Sciences' Webb Building), and the family will pick up the food during their weekly meeting with the study dietitian. This method is popular with participants, logistically feasible, and has worked very well to encourage diet adherence and attendance of study visits. Our staff has developed recipes, meal plans, and food lists that will govern the grocery selection, and will assist with implementation of the diets by providing specific meal plans and recipes. The meal plans will be prepared using Nutrition Data System for Research (NDSR), which provides a comprehensive output of diet composition including macro- and micro-nutrients, glycemic index, glycemic load, and vitamins. Meal plans may be modified after the participants become familiar with their diets, allowing for participant choice of favorite foods and meals. Based on our previous intervention, the investigators do not anticipate any difficulties with adhering to the diets for 12 weeks. Both diets will be prescribed at a weight-maintaining energy level [1.46-1.62 for females or 1.54-1.86 for males (depending on age and activity level) x measured resting energy expenditure to avoid confounding by changes in body weight. Body weight will be monitored weekly, and any participant who demonstrates consistent weight gain or loss will have their prescription revised.
Although meals will be prescribed, both diet groups will be asked to verify what they ate each week. They will be given detailed weekly meal plans in the form of a checklist, and asked to verify that each food was consumed in the prescribed amount, or to write down any deviation from the prescription.
Free living phase (Phase 2) All participants in both treatment groups will be asked to continue their assigned diet during the free-living phase when groceries are not provided. The study dietitian will work with families to devise a diet prescription that will both meet their prescribed diet guidelines and is also affordable and accessible to the families.
b.Self-monitoring: Self-monitoring of diet and exercise behaviors has repeatedly been found to be a key behavior strategy for improving adherence. Children and parents in the study will be asked to self-monitor their diet using a food recording app.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Being tested
- Moderately carbohydrate-restricted diet, Fat-restricted diet
- Keywords
- NAFLD, Obesity, Insulin sensitivity
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderately carbohydrate-restricted dietOther
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.
Fat-restricted dietOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Moderately carbohydrate-restricted diet | Experimental | 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. Receives: Other: Moderately carbohydrate-restricted diet |
| Fat-restricted diet | Active comparator | 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). Receives: Other: Fat-restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic lipid
Hepatic lipid will be measured using MRI and Magnetic resonance spectroscopy (MRS).
Measured: Baseline
Hepatic lipid
Hepatic lipid will be measured using MRI and MRS.
Measured: 3 months
Hepatic lipid
Hepatic lipid will be measured using MRI and MRS.
Measured: 6 months
Secondary outcomes (7)
Hepatic insulin sensitivity
Insulin sensitivity will be measured using a euglycemic, hyperinsulinemic clamp with deuterium-labeled glucose tracers
Measured: Baseline
Hepatic insulin sensitivity
Insulin sensitivity will be measured using a euglycemic, hyperinsulinemic clamp with deuterium-labeled glucose tracers
Measured: 3 months
Plasma metabolome
Metabolomic profile will be assessed from a fasted blood sample.
Measured: Baseline
Plasma metabolome
Metabolomic profile will be assessed from a fasted blood sample.
Measured: 3 months
Body composition
Body composition will be assessed using Dual energy X-ray absorptiometry
Measured: Baseline
Body composition
Body composition will be assessed using Dual energy X-ray absorptiometry
Measured: 3 months
Body composition
Body composition will be assessed using Dual energy X-ray absorptiometry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2022
- Study start1 May 2022
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The objective of this parallel arm, randomized clinical trial is to use a 6-month family-based intervention with 2 phases, a 12-week controlled feeding and 12-week free-living phase, to examine the effects of weight maintaining, moderately carbohydrate-restricted vs fat-restricted diets in adolescents with NAFLD on depletion of hepatic lipid, improvement in hepatic insulin sensitivity, and changes in the plasma metabolome.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Miskimon Goss, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05268042
- Sponsor's protocol ID
- IRB-300007416
- Other IDs
- R01DK128457
- Status last verified
- Jul 2026
- First submitted
- 15 Feb 2022
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Moderately Carbohydrate-restricted Diet as Treatment Targeting Improvement in Hepatic Lipid and Insulin Sensitivity in Adolescents With NAFLD
- ClinicalTrials.gov ID
- NCT05268042
- Acronym / sponsor ID
- IRB-300007416
- Conditions
- Non-Alcoholic Fatty Liver Disease, Obesity
- Keywords
- NAFLD, Obesity, Insulin sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 May 2022 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 7 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Under energy balance conditions when carbohydrates are restricted, protein or fat will increase. Large increases in dietary protein are undesirable due to the potential stimulation of hepatic gluconeogenesis. If dietary fat is increased, attention should be paid to the quality or composition of this fat. In order to minimize differences in the quality and composition of fats included in both diets, consumption of similar proportions and sources of saturated, mono-and polyunsaturated fats will be emphasized. Increased intake of polyunsaturated fats (ω-3 and ω-6) have been shown to decrease hepatic inflammation, improve hepatic function, and inhibit de novo lipogenesis; thus, diets will provide a 4:1 ratio of poly- to monounsaturated fatty acids. Because the carbohydrate-restricted diet will limit total grams of carbohydrate, total fat will increase thereby increasing the amount of dietary cholesterol provided by the diet, which may be unavoidable. However, the diet prescriptions will be matched for and provide adequate sodium intake.
carbohydrate-restricted diet. For this study, the investigators will use the low glycemic, 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. The investigators have successfully incorporated a limited number of "convenience" foods in our carbohydrate-restricted diet.. Incorporation of these foods increases the ultimate translatability of the carbohydrate-restricted diet, and the likelihood that participants can and will continue with the diet on their own initiative. Thus, the investigators will include some convenience foods in this study, as appropriate for the individual participant's needs. 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. These products provide specific fatty acids that will be used to assess adherence. Saturated fat will be limited to less than 10% of daily total fat intake. Patients will obtain the majority of their fat intake from poly- and mono-unsaturated fatty acids at a 4:1 ratio (from nuts, nut butters, and from fresh fish), and saturated fat will be primarily derived from medium-chain triglycerides (e.g., coconut oil and cream), some meat, and dairy.
Fat-restricted diet. 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 less than 10% of total fat intake, and all dairy products will be fat-free (or low fat). Patients will obtain the majority of their fat intake from poly- and mono-unsaturated fatty acids at a 4:1 ratio matched to the carbohydrate-restricted group; however, total grams will be lower. Although the fat-restricted diet will be a high quality, healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the carbohydrate-restricted diet. In addition, it will have a higher glycemic load than the carbohydrate-restricted diet. Thus, the greater glycemic load of the fat-restricted diet will derive from both inclusion of foods with a higher glycemic index and incorporation of a greater proportion of total energy from carbohydrates.
Controlled feeding phase (Phase 1) During the first 12-weeks, all food will be provided to participants. Participants will receive their weekly groceries via home delivery from a grocery store via a grocery delivery service. The study dietitian will order all groceries on-line, and the groceries will be delivered to the participants at their selected time and date. In cases where the participant's family lives outside of delivery zones, the food will be delivered to University of Alabama at Birmingham (UAB) (the Department of Nutrition Sciences' Webb Building), and the family will pick up the food during their weekly meeting with the study dietitian. This method is popular with participants, logistically feasible, and has worked very well to encourage diet adherence and attendance of study visits. Our staff has developed recipes, meal plans, and food lists that will govern the grocery selection, and will assist with implementation of the diets by providing specific meal plans and recipes. The meal plans will be prepared using Nutrition Data System for Research (NDSR), which provides a comprehensive output of diet composition including macro- and micro-nutrients, glycemic index, glycemic load, and vitamins. Meal plans may be modified after the participants become familiar with their diets, allowing for participant choice of favorite foods and meals. Based on our previous intervention, the investigators do not anticipate any difficulties with adhering to the diets for 12 weeks. Both diets will be prescribed at a weight-maintaining energy level [1.46-1.62 for females or 1.54-1.86 for males (depending on age and activity level) x measured resting energy expenditure to avoid confounding by changes in body weight. Body weight will be monitored weekly, and any participant who demonstrates consistent weight gain or loss will have their prescription revised.
Although meals will be prescribed, both diet groups will be asked to verify what they ate each week. They will be given detailed weekly meal plans in the form of a checklist, and asked to verify that each food was consumed in the prescribed amount, or to write down any deviation from the prescription.
Free living phase (Phase 2) All participants in both treatment groups will be asked to continue their assigned diet during the free-living phase when groceries are not provided. The study dietitian will work with families to devise a diet prescription that will both meet their prescribed diet guidelines and is also affordable and accessible to the families.
b.Self-monitoring: Self-monitoring of diet and exercise behaviors has repeatedly been found to be a key behavior strategy for improving adherence. Children and parents in the study will be asked to self-monitor their diet using a food recording app.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The objective of this parallel arm, randomized clinical trial is to use a 6-month family-based intervention with 2 phases, a 12-week controlled feeding and 12-week free-living phase, to examine the effects of weight maintaining, moderately carbohydrate-restricted vs fat-restricted diets in adolescents with NAFLD on depletion of hepatic lipid, improvement in hepatic insulin sensitivity, and changes in the plasma metabolome.
| Arm | Type | Receives |
|---|---|---|
| Moderately carbohydrate-restricted diet | Experimental | Other: Moderately carbohydrate-restricted dietFor 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. |
| Fat-restricted diet | Active comparator | Other: Fat-restricted dietThe 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). |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderately carbohydrate-restricted dietFor 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. | Other | Moderately carbohydrate-restricted diet |
| Fat-restricted dietThe 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). | Other | Fat-restricted diet |
Primary outcome
Hepatic lipid
Time frame: Baseline
Hepatic lipid will be measured using MRI and Magnetic resonance spectroscopy (MRS).
Hepatic lipid
Time frame: 3 months
Hepatic lipid will be measured using MRI and MRS.
Hepatic lipid
Time frame: 6 months
Hepatic lipid will be measured using MRI and MRS.
7 secondary outcomes
Hepatic insulin sensitivity
Time frame: Baseline
Hepatic insulin sensitivity
Time frame: 3 months
Plasma metabolome
Time frame: Baseline
Plasma metabolome
Time frame: 3 months
Body composition
Time frame: Baseline
Body composition
Time frame: 3 months
Body composition
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderately carbohydrate-restricted diet and Fat-restricted diet in people with Non-Alcoholic Fatty Liver Disease and Obesity, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hepatic lipid (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.