Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT06356220
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Sponsor:
Boston Children's Hospital
Organization:
Study Overview
Official Title:
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GF-NOURISH
Brief Summary:
The investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits
Detailed Description:
Celiac Disease (CeD) is a gluten driven enteropathy that affects up to 3% of the population and typically develops in childhood. Lifelong adherence to a gluten-free diet (GFD) is the primary treatment. Rice, the most common gluten-free substitute grain, naturally bioaccumulates inorganic arsenic. Chronic arsenic exposure may affect neurodevelopment, increase risk of cardiovascular disease and cause kidney damage. In a prior prospective cohort study, the investigators demonstrated that urine arsenic levels increased 2-3 times in newly diagnosed children 6 months after adoption of a GFD. This likely is a consequence of both impaired absorption of vitamin B12 and folate in the small intestine (both nutrients are part of the pathway to excrete arsenic from the body) and increased ingestion of rice products on a gluten-free diet. In particular, gluten-free ultra-processed free foods tend to be specialty products that are made predominantly from rice products, easy for families to identify as safe when avoiding gluten, and rarely fortified with vitamins. Ultra-processed food(UPF) consumption has also been associated with lower perceived quality of life in patients with CeD.
Given the risks associated with gluten-free ultra-processed food, the investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits
The investigators propose to randomize (1:1) 120 children at celiac disease diagnosis to either a novel nutritional education (GF-NOURISH) focused on minimizing ultra-processed gluten free foods or to a conventional GFD nutritional education. Urine/Hair/Toenail arsenic, changes in percent fat free mass, household budgets, diet quality measurements will be evaluated after 6 months on the GFD.
Given the risks associated with gluten-free ultra-processed food, the investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits
The investigators propose to randomize (1:1) 120 children at celiac disease diagnosis to either a novel nutritional education (GF-NOURISH) focused on minimizing ultra-processed gluten free foods or to a conventional GFD nutritional education. Urine/Hair/Toenail arsenic, changes in percent fat free mass, household budgets, diet quality measurements will be evaluated after 6 months on the GFD.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: