NCT05268042Completed
Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents
Moderately Carbohydrate-restricted Diet as Treatment Targeting Improvement in Hepatic Lipid and Insulin Sensitivity in Adolescents With NAFLD
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 15 Feb 2022
- Start date
- 1 May 2022
- Primary completion date
- 21 Jul 2026
- Lead sponsor
- University of Alabama at Birmingham
- Diseases
- Obesity, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT05268042
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 May 2022 to the primary completion date, 21 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- currently receiving intense lifestyle modification treatment
- alcohol, tobacco or recreational drug use
Other illness
- 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)
- autoimmune liver disease
- metabolic liver disease
- Wilson's disease
- genetic conditions (e.g. glycogen storage disorder) leading to hepatic steatosis;
- history of bariatric surgery
Lab values
- HbA1c \>7%
- estimated Glomerular Filtration Rate (eGFR) \<60
Other
- pregnancy
- 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
- unable to undergo MRI.
Who the study is looking for
- 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).
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.