Comparison of Dietary Sugar Reduction Methods

Not Applicable

Completed

• Conditions: Nonalcoholic Fatty Liver Disease
• Interventions: Other: Diet Provision Group; Behavioral: Guided Grocery Shopping (GGS)

• Registration Number: NCT04186793
• Lead Sponsor: Emory University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-03
• Study First Posted: 2019-12-05
• Study Start: 2020-02-06
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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)

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet Provision Group	Diet Provision Group	Participants in this study arm will be provided with a diet low in free sugars. This intervention replaces the habitual diet with a low "free sugars" diet (goal of \<3% of total calories).
Guided Grocery Shopping	Guided Grocery Shopping (GGS)	Participants in this study arm will receive a guided grocery shopping intervention for four weeks.

Primary Outcome Measures

Name	Time	Method
Change in Percent of Calories from Free Sugars	Baseline, Week 4, Week 24	The percent of calories from free sugars in the GGS group will be compared to the diet provision group. Participants will complete a dietary recall covering three 24-hour periods.

Secondary Outcome Measures

Name	Time	Method
Ability to Sustain Diet	Week 4, Week 24	Perception of the ability to sustain the diet will be assessed qualitatively. Semi-structured interviews will be performed with the participant and their parent/guardian at the end of the study to assess their ability to achieve and maintain a low sugar diet.
Diet compliance	Week 4, Week 24	Perception of diet compliance difficulty will be assessed qualitatively. Semi-structured interviews will be performed with the participant and their parent/guardian at the end of the study to ascertain their experience during the intervention

Trial Locations

Locations (2)

Emory University; 🇺🇸 Atlanta, Georgia, United States

Children's Healthcare of Altanta; 🇺🇸 Atlanta, Georgia, United States