Status:
RECRUITING
Moderately Carbohydrate-restricted Diet to Treat NAFLD in Adolescents
Lead Sponsor:
University of Alabama at Birmingham
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Non-Alcoholic Fatty Liver Disease
Obesity
Eligibility:
All Genders
10-17 years
Phase:
NA
Brief 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 f...
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 gluconeo...
Eligibility Criteria
Inclusion
- 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 10 -17 yrs
- overweight or obese (BMI \>75th percentile).
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05268042
Start Date
May 1 2022
End Date
May 1 2026
Last Update
May 20 2025
Active Locations (1)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35226