Clinical trial NCT06356220: GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Official title: GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Celiac Disease in Children
Nutrition Disorder, Child
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Study Design: Prospective randomized controlled trial.
2. Study population: Children (N=120) with newly diagnosed CeD
3. Intervention: Gluten-Free Food Guide, a nutritional education program focused on minimizing ultra-processed foods in gluten-free die(GFFG), OR a conventional GFD nutritional education class. The nutrition educational program will be based on validated GFD education program. The investigators will use a randomized control trial to assess improvement of overall diet quality, changes in body composition, and minimize toxic and nutrient metal exposures associated with processed gluten-free foods.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass
timeFrame: Over 6 months
Secondary outcomes:
measure: To compare the effect of GFFG vs conventional GFD class on diet quality
timeFrame: Over 6 months
measure: To compare the effect of GFFG versus conventional GFD on arsenic exposure
timeFrame: Over 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References: