Overview

This trial is active, not recruiting.

Condition non-alcoholic fatty liver disease
Treatments experimental: low-fructose, reduced carbohydrate diet, general healthy diet
Sponsor University of Wisconsin, Madison
Start date April 2014
End date July 2016
Trial size 28 participants
Trial identifier NCT02116192, K12HD055894

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
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)
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)
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.
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.

Primary Outcomes

Measure
Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF
time frame: 6 months

Secondary Outcomes

Measure
Metabolic biomarkers
time frame: 6 months
PNPLA3 genotype
time frame: 6 months
Novel free breathing hepatic MR PDFF protocol
time frame: 6 months

Eligibility Criteria

Male or female participants from 11 years up to 17 years old.

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.

Additional Information

Official title Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
Principal investigator Jennifer Rehm, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.