Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04186793 |
Other study ID # |
IRB00115167 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 6, 2020 |
Est. completion date |
December 15, 2021 |
Study information
Verified date |
March 2022 |
Source |
Emory University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.