SMART Diets for MASLD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age11-17
SponsorMichigan State University
About this trial
This phase 2 trial is a single-site sequential, multiple assignment, randomized trial (SMART) to test and construct a high-quality adaptive intervention of essential amino acids (EAA) and/or Low Sugar Diet for children with metabolic dysfunction associated steatotic liver disease (MASLD) and increased cardiometabolic risk. The basis for the trial includes high-quality pilot data in both EAA for hepatic steatosis and a low sugar diet for hepatic steatosis. In the trial, children aged 11-17 years old will be eligible to participate if their BMI is greater than or equal to 95th% at baseline and hepatic steatosis is greater than or equal to 8% at baseline by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) because this is the most common age group diagnosed with metabolic-dysfunction associated steatotic liver disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children 11 to 17-years-old at the time of consenting
Hepatic Steatosis by MRI greater than or equal to 8% on baseline MRI
At least 1 of the following cardiometabolic risk factors: BMI greater than or equal to 85th percentile for age/sex or WC greater than 95th percentile, Abnormal cholesterol or triglyceride levels, Blood pressure BP greater than or equal to 95th percentile OR greater than or equal to 130/80 and/or signs of insulin resistance (Acanthosis Nigricans OR HOMA-IR of greater 2.0 and greater 2.6 in prepubertal and pubertal children, respectively, Fasting Insulin Level of 10 pIU/mL in prepubertal children and of 17 pIU/mL and 13 pIU/mL in pubertal girls and boys, respectively, OR Prediabetes)
ALT greater than or equal to 40 U/L
Disqualifiers
Patients with Diagnosed Type 2 or Type 1 Diabetes Mellitus (T2DM) or HbA1c of >6.5 mg/dL at baseline
Patients diagnosed with or suspected to have a chronic liver disease other than MASLD by screening labs or evaluation (i.e autoimmune, viral). Screening labs are defined as: Hepatitis B surface antigen, Hepatitis C virus total antibody, IgG, ceruloplasmin, and alpha 1 antitrypsin phenotype.
Patients unable to complete MRI or Labs required for the study.
Current participation in another clinical trial
Trial design
Design model
Sequential
Treatments tested in this trial
Essential Amino Acids Supplementation intervention
DrugEAA supplement contains the following formulation: histidine, isoleucine, leucine, lysine, phenylalanine, threonine, and valine
Low sugar diet
Other interventionThe Low Sugar Diet uses the adapted and extended Social Cognitive Theory (SCT) guided low sugar intervention. The registered dietitian nutritionist (RDN) helps families to identify foods high in sugar and to identify acceptable replacements in order to remove foods and drinks high in free sugar from the home and replacement with low or no free sugar containing similar foods.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Essential Amino Acids SupplementationActive comparator 1 intervention
Group B: Low Sugar DietActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in hepatic steatosis
Change in hepatic steatosis by magnetic resonance imaging (MRI)
Time frame
Baseline to 24 weeksSecondary outcomes
1
Change in fasting triglyceride
Change in triglyceride in mg/dL
Time frame
Baseline, 12 and 24 weeks2
Change in HDL
Change in HDL mg/dL
Time frame
Baseline, 12 and 24 weeks3
Change in VLDL-triglyceride
Very-low-density-lipoprotein triglyceride
Time frame
Baseline, 12 and 24 weeks4
Change in Waist circumference
Change in Waist circumference in cm
Time frame
Baseline, 12 and 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Michigan State University
Lead sponsor
Emory University
Collaborator
Corewell Health West
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov