GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

Boston Children's Hospital

Status: Enrolling

Conditions: Celiac Disease in Children; Nutrition Disorder, Child

Treatments: Other: Gluten-Free Diet Education

Study type: Interventional

Funder types: Other

Identifiers

NCT06356220

IRB-P00046867

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 2-18 years of age with recent celiac disease diagnosis

Exclusion criteria

• Allergic to <3 of the top 8 food allergens
• Co-morbid conditions treated with dietary modifications or that influence nail arsenic values

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

GFFG

Experimental group

Description:

Our Canadian collaborators have created Gluten Free-Food Guide (GFFG), a validated nutritional educational intervention, which targets increasing consumption of natural gluten free foods and limiting UPFs. However, this intervention has not yet been applied to a pediatric cohort in the United States. Preliminary data demonstrate enrollment feasibility and generalizability of the intervention. The GFFG arm will have increased focus on plant proteins, minimally processed food intake and fruit/vegetable intake with emphasis on naturally gluten-free foods. The GFFG class will highlight that not all gluten-free foods have the same nutritional and health benefits.

Treatment:

Other: Gluten-Free Diet Education

Conventional GFD Nutrition Education

Active Comparator group

Description:

Diet counselling in both the conventional GFD nutrition education and the GFFG intervention arm will include concepts related to nutrition literacy (food label reading, gluten identification, nutritional adequacy). The control group will be provided with the GFFG at the end of the study.

Treatment:

Other: Gluten-Free Diet Education