Comparison of Dietary Sugar Reduction Methods
Completed · Not applicable
Conditions studied: Nonalcoholic Fatty Liver Disease
In brief
This is a two arm, randomized, 4 week study comparing 2 methods of dietary sugar reduction at Emory University and Children's Healthcare of Atlanta. Participants will be non-diabetic children with NAFLD. Two groups of 6 participants will be followed for 4 weeks during the randomized controlled trial followed by a 20 week follow-up extension. One group will receive a guided grocery shopping (GGS) intervention for 4 weeks while the other group will be provided with a low free sugars (\<3% total daily) diet. The goal of this study is to determine if guided grocery shopping (GGS) over 4 weeks is equivalent to complete family diet provision in reducing free sugar intake to \<3% of total energy (TE) and if GGS will sustain the dietary change over 6 months.
Key facts
- Study ID
- NCT04186793
- Run by
- Emory University
- People needed
- 8
- Starts
- 2020-02-06
- Expected to finish
- 2021-12-15
- Last updated by the study team
- 2022-03-25
Who can join
Age: 8 and older, up to 16. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Clinical history consistent with NAFLD
- Written informed consent from parent or legal guardian
- Written or verbal informed assent from the child
- Currently regularly consumes sugary beverages ( ≥ 2 eight ounce sugar drinks or juice per week)
You may not qualify if…
- Participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigators
- History of significant depression
- Diabetes
- Evidence of other chronic liver disease
- Children who are currently enrolled in a clinical trial or who received an investigational study drug or dietary intervention within the past 60 days
- Participants who are not able or willing to comply with the diet protocol or have any other condition that would impede compliance or hinder completion of the study, in the opinion of the investigator
- Families with > 6 individuals
Where it is running
- Children's Healthcare of Altanta — Atlanta, Georgia, United States
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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