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

University of Wisconsin (UW)

Status: Completed

Conditions: Non-alcoholic Fatty Liver Disease

Treatments: Behavioral: General Healthy Diet; Behavioral: Experimental: Low-fructose, reduced carbohydrate diet

Study type: Interventional

Funder types: Other

Identifiers

NCT02116192

K12HD055894

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 11 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

General Healthy Diet

Active Comparator group

Description:

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)

Treatment:

Behavioral: General Healthy Diet

Low-fructose, reduced carbohydrate diet

Experimental group

Description:

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.

Treatment:

Behavioral: Experimental: Low-fructose, reduced carbohydrate diet