Clinical trial NCT04186793: Comparison of Dietary Sugar Reduction Methods
Official title: Comparison of Dietary Sugar Reduction Methods
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: Pediatrics
Obesity
Liver Disease
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Center for Cystic Fibrosis and Airways Disease Research
First posted: 2019-12-05
Enrollment: 8
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Nonalcoholic fatty liver disease (NAFLD) is a condition in which abnormal amounts of fat deposit in the liver. This ectopic deposition of triglycerides is metabolically harmful to the liver and is strongly associated with dysregulation of lipid metabolism and insulin resistance. NAFLD is increasing in prevalence in children and now is estimated to affect \~30% of obese children in the U.S. and 6-15% of children across the world. The severity of the disease ranges widely, from mild with increased fat (steatosis) alone to more severe phenotypes of steatosis, inflammation and hepatocyte ballooning (called steatohepatitis) to cirrhosis. While the natural course of pediatric NAFLD is not fully understood, in adults, progression to cirrhosis occurs in about 10%. Diabetes is strongly associated with NAFLD and in children the incidence of prediabetes and diabetes in children with NAFLD is 3 to 5% per year, markedly increases from population estimates of 3.5/cases per 100,000.

Because of the high prevalence of NAFLD, especially among children with obesity, and the increased mortality and morbidity associated with NAFLD, it has become a focus for therapeutic development. In children, there have been several phase 2 clinical trials, but to date there no approved medications for NAFLD. The current standard of care for pediatric NAFLD treatment is healthy diet and exercise. Which "healthy diet" to apply is unknown. Short term evidence in adults supports a variety of approaches including Mediterranean diet, low-fat diet, and low-carbohydrate diet.

For children, there has been a focus on diet quality rather than weight loss. In totality, research demonstrates that consumption of free sugars leads to increased triglycerides, decreased high density lipoprotein cholesterol (HDLc) and increased very low density lipoprotein (VLDL) size, as well as endotoxemia, while reduction of free sugars improves hepatic fat and inflammation.

Complete diet provision is established as an effective research tool to test a diet modification. However, this approach becomes impractical, unsustainable, and expensive when applied across a large multicenter trial. Consequently, less intensive methods would be highly beneficial, if they are equally effective in modifying the diet. Thus, this randomized equivalence pilot study has been designed to test if facilitated grocery shopping will be equivalent to complete diet provision in reducing free sugar consumption to ≤ 3% in children with NAFLD.

This is a 4-week randomized, controlled, outpatient feeding study 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 24 weeks. This will include 4 weeks during which the randomized controlled trial will be conducted, followed by a 20 week follow-up. One group will receive the guided grocery shopping (GGS) intervention for 4 weeks while the other group will be provided with a low free sugars (goal of \<3% total daily calories) version of their family's habitual diets. Both groups will receive diet/nutrition counseling and support once per week during the intervention period.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Percent of Calories from Free Sugars
timeFrame: Baseline, Week 4, Week 24
Secondary outcomes:
measure: Diet compliance
timeFrame: Week 4, Week 24
measure: Ability to Sustain Diet
timeFrame: Week 4, Week 24
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Altanta
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Miriam Vos, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: