Non-alcoholic Fatty Liver Disease
Conditions
Keywords
Non-alcoholic Fatty Liver Disease, Adolescent
Brief summary
This research study intends to learn about whether early intervention can help to prevent non-alcoholic fatty liver disease (NAFLD) in adolescents. Potentially eligible adolescents who are seen at the University of Wisconsin (UW) Pediatric Fitness Clinic will be asked to join the study. Patients who agree to participate in the study will be randomized into either the intervention group or the control group. The intervention group will follow a low-fructose diet. In addition, participants will be asked to return to the clinic for 4 follow-up visits during a 6-month interval.
Detailed description
This will be a prospective, randomized, controlled trial for obese adolescents. Sixty obese youth (male and female), age 11-17 years with BMI \>95 %tile for age and sex and one parent/guardian will be recruited for inclusion into the study at an initial pediatric fitness clinic visit. Consented subjects will be stratified by gender and ethnicity and randomized into low fructose or standard weight loss dietary intervention groups.
Interventions
BEHAVIORALExperimental: Low-fructose, reduced carbohydrate diet
Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat) ● Aim for less than 25g fructose daily.
BEHAVIORALGeneral Healthy Diet
Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 11-17 years of age * BMI \>95%tile for age and sex * Being seen for an initial clinic visit at the UW Pediatric Fitness Clinic * Parent willing to participate in study
Exclusion criteria
* History of chronic disease that effects hepatic or renal function including: Type 1 or Type 2 diabetes mellitus, known liver disease or other chronic illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic biomarkers | 6 months | Including waist circumference (WC), blood pressure (BP), insulin resistance measured by homeostasis model assessment (HOMA-IR), lipids, ALT, androgens, and visceral and subcutaneous adiposity (by MR PDFF), and cardiovascular fitness (sub-maxVO2 test), in low carbohydrate/low fructose and standard weight-reduction diet groups |
| PNPLA3 genotype | 6 months | — |
| Novel free breathing hepatic MR PDFF protocol | 6 months | — |
Countries
United States
Outcome results
None listed