Dietary Treatment Study of Pediatric NAFLD (DTS)

January 16, 2020 updated by: Jeffrey B. Schwimmer, MD, University of California, San Diego

Randomized, Controlled Dietary Treatment Study of Pediatric NAFLD

This is an investigator initiated study being conducted in equal numbers at two sites, University of California, San Diego (UC San Diego) and Emory University (EU). The purpose of this study is to understand the potential of a low sugar diet for the treatment of nonalcoholic fatty liver disease (NAFLD) in children. Forty boys with NAFLD will be randomly assigned to either an intervention group or a habitual diet control group. The intervention will be a low sugar diet for a period of 8 weeks. The effect of this dietary change will be assessed using advanced magnetic resonance imaging (MRI) testing to measure liver fat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92093
        • University of California, San Diego
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Boys age 11-16 years inclusive.
  • Clinical history consistent with NAFLD.
  • Biopsy-proven NAFLD
  • MRI measured Liver Proton Density Fat Fraction ≥10%
  • alanine aminotransferase (ALT) ≥ 45 u/L
  • No evidence of any other liver disease by clinical history or histological evaluation.
  • Written informed consent from parent or legal guardian.
  • Written informed assent from the child or adolescent.

Exclusion Criteria:

Exclusions will not be based upon gender, race, or ethnicity. Participants with a current history of the following conditions or any other health issues that make it unsafe for them to participate in the opinion of the Investigators will be excluded from the study:

  • History of significant alcohol intake (Alcohol Use Disorders Identification Test [AUDIT]) or inability to quantify alcohol consumption
  • Chronic use (more than 2 consecutive weeks) of medications known to cause hepatic steatosis or steatohepatitis in the past year.
  • The use of other known hepatotoxins within 120 days of baseline
  • History of total parenteral nutrition (TPN) use in the year prior to screening
  • History of bariatric surgery or planning to undergo bariatric surgery during the study duration
  • Significant depression
  • Non-compensated liver disease with any one of the following hematologic, biochemical, and serological criteria on entry into protocol:
  • Hemoglobin < 10 g/dL
  • White blood cell < 3,500 cells/mm
  • Neutrophil count < 1,500 cells/mm3 of blood
  • Platelets < 130,000 cells/mm3 of blood
  • Direct bilirubin > 1.0 mg/dL
  • Total bilirubin > 3 mg/dL
  • Albumin < 3.2 g/dL
  • International normalized ratio (INR) > 1.4
  • Evidence of other chronic liver disease
  • Children who are currently enrolled in a clinical trial or who received an investigational study drug or a medication with the intent to treat NAFLD/NASH in the past 60 days
  • Contraindications to MRI, e.g. metal in the eyes, implanted electronic devices, aneurysm clips, pacemaker, cochlear implants
  • Unable to have or complete the MRI exam due to body weight exceeding scanner table limit or girth exceeding scanner bore diameter
  • Subjects who are not able or willing to comply with the protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
  • Families with > 5 individuals
  • Failure to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dietary modification
Low free sugar diet
Other: Dietary modification
The intervention is a modification of the family's habitual diet with a low sugar version of their diet.
No Intervention: Observational Arm
Standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Percentage of Liver Fat Measured by Magnetic Resonance Imaging (MRI) in the Intervention Group Compared to Change in the Control Group
Time Frame: Measurements done at baseline and week 8.
The principal objective of this randomized and controlled pilot study is to evaluate whether 8 weeks of a low added sugar diet (<3%) in boys with NAFLD will change liver fat % measured by MRI.
Measurements done at baseline and week 8.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Alanine Aminotransferase (ALT) From Baseline to Week 8
Time Frame: Measurements done at baseline and week 8
Measurements done at baseline and week 8
Change in Aspartate Aminotransferase (AST) From Baseline to Week 8
Time Frame: Measurements doen at baseline and week 8
Measurements doen at baseline and week 8
Change in Gamma-Glutamyl Transpeptidase (GGT) From Baseline to Week 8
Time Frame: Measurements done at baseline and week 8
Measurements done at baseline and week 8
Change in Insulin From Baseline to Week 8
Time Frame: Measurements done at baseline and week 8
Measurements done at baseline and week 8
Change in Homeostasis Model Assessment- Insulin Resistance (HOMA-IR) From Baseline to Week 8
Time Frame: Measurements done at baseline and week 8
HOMA-IR was calculated as follows: fasting insulin (µU/mL) x fasting glucose (nmol/L)/22.5
Measurements done at baseline and week 8
Change in Triglycerides From Baseline to Week 8
Time Frame: Measurements done at baseline and week 8
Measurements done at baseline and week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

Emory University
Nutrition Science Initiative

Investigators

  • Principal Investigator: Jeffrey B Schwimmer, MD, University of California, San Diego

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

July 29, 2015

First Submitted That Met QC Criteria

July 29, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 16, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-4405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data will be made available in response to bona fide and good faith, ad hoc requests. Suitability of each request, if consistent with Institutional Review Board (IRB) approval, will be determined only in the case of a favorable vote of a majority of a committee consisting of each consortium investigator and the Grantor. Data will be made available with a signed access agreement.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Nonalcoholic Fatty Liver Disease

Clinical Trials on Dietary modification

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe