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Completed

NCT Number: NCT02116192

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Park Clinic

Madison, Wisconsin, 53711, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Experimental: Low-fructose, reduced carbohydrate diet

Behavioral

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.

General Healthy Diet

Behavioral

Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat

Primary outcomes

  1. Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF

    Time frame: 6 months

Secondary outcomes

  1. 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

  2. PNPLA3 genotype

    Time frame: 6 months

  3. Novel free breathing hepatic MR PDFF protocol

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Acronym: NAFLD

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Apr 16, 2014
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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