Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2016

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

  • Behavioral: Experimental: 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.
  • Behavioral: General Healthy Diet
    • Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat

Arms, Groups and Cohorts

  • Active Comparator: General Healthy Diet
    • Control: General Healthy Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat)
  • Experimental: Low-fructose, reduced carbohydrate diet
    • Intervention: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF
    • Time Frame: 6 months

Secondary Measures

  • Metabolic biomarkers
    • Time Frame: 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
    • Time Frame: 6 months
  • Novel free breathing hepatic MR PDFF protocol
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 11 Years

Maximum Age: 17 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Wisconsin, Madison
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jennifer Rehm, MD, Principal Investigator, University of Wisconsin, Madison

References

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