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

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Experimental: Low-fructose, reduced carbohydrate diet
General Healthy Diet
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non-alcoholic Fatty Liver Disease focused on measuring Non-alcoholic Fatty Liver Disease, Adolescent

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept 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.

Sites / Locations

  • Research Park Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

General Healthy Diet

Low-fructose, reduced carbohydrate diet

Arm 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)

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.

Outcomes

Primary Outcome Measures

Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF

Secondary Outcome Measures

Metabolic biomarkers
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
Novel free breathing hepatic MR PDFF protocol

Full Information

First Posted
April 14, 2014
Last Updated
October 9, 2018
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT02116192
Brief Title
Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
Acronym
NAFLD
Official Title
Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Non-alcoholic Fatty Liver Disease, Adolescent

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Healthy Diet
Arm Type
Active Comparator
Arm 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)
Arm Title
Low-fructose, reduced carbohydrate diet
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Experimental: Low-fructose, reduced carbohydrate diet
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
General Healthy Diet
Intervention Description
Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat
Primary Outcome Measure Information:
Title
Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Metabolic biomarkers
Description
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
Time Frame
6 months
Title
PNPLA3 genotype
Time Frame
6 months
Title
Novel free breathing hepatic MR PDFF protocol
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Rehm, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Park Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States

12. IPD Sharing Statement

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

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