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

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ClinicalTrials.gov Identifier: NCT02116192
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Behavioral: Experimental: Low-fructose, reduced carbohydrate diet Behavioral: General Healthy Diet Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Early Intervention and Prevention of Non-Alcoholic Fatty Liver Disease in Adolescents
Study Start Date : April 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fructose

Arms and Interventions
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Arm Intervention/treatment
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)
 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
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.

 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.


Outcome Measures
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Primary Outcome Measures :
  1. Hepatic triglyceride content measured by Magnetic resonance (MR) PDFF [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   11 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116192


Locations
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United States, Wisconsin
Research Park Clinic
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Jennifer Rehm, MD University of Wisconsin, Madison
More Information
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Publications:

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02116192    
Other Study ID Numbers: K12HD055894 ( U.S. NIH Grant/Contract )
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by University of Wisconsin, Madison:
Non-alcoholic Fatty Liver Disease
Adolescent
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases