GF-NOURISH (Gluten Free Nutrition Optimization Through Ul... | NCT06356220

Status Module

Oversight Module

Description Module

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GFFG	Experimental	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.	Other: Gluten-Free Diet Education
Conventional GFD Nutrition Education	Active Comparator	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.	Other: Gluten-Free Diet Education

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Gluten-Free Diet Education	Other	The two groups will receive different gluten free diet education interventions. Currently, virtual GFD education classes are the standard of care for educating children with CeD and their families about GFD at Boston Children's Hospital. Thus, all diet education (including GFFG intervention) will be provided virtually by Registered Dietitians with expertise in GFDs. .

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass	While the gold standard measurement for body composition is dual energy X-ray absorptiometry (DEXA) or underwater weighing and air displacement plethysmography (BodPod), these techniques require special facilities that increase cost, are difficult to perform in outpatient settings. DEXA scans also involve radiation exposure. Therefore, the investigators will use bio-impedance spectroscopy analysis (BSA), which is a simple, noninvasive, reproducible, portable and convenient method to measure body composition.26 BSA utilizes body resistance and reactance to derive phase angle (PhA) and estimate the fat (FM) and non-fat (FFM) components of the body	Over 6 months

Secondary Outcomes

Measure	Description	Time Frame
To compare the effect of GFFG vs conventional GFD class on diet quality	Given that one of primary objectives of the GFFG is to decrease ultra-processed gluten-free foods (UPGFF), this aim focuses on assessing the impact of the nutrition education intervention on participant's recorded UPF consumption and diet quality. All participants will fill out a three-day food frequency record at study entry and six months of GFD. Food items will be classified by the NOVA system: the most used identification system for UPFs. Of the four leading food processing-based classification systems (NOVA, IARC(International Agency for Research on Cancer), IFIC(International Food Information Council) and UNC(University of North Carolina)), NOVA has been used in 95% of studies on consumption of highly processed foods and chronic health outcome published between 2015 and 2019 in children and adults. NOVA categorizes all the foods by level of food processing: i) unprocessed or minimally processed, (ii) processed culinary ingredients, (iii) processed foods and (iv) UPFs.

Eligibility Module

ID	Term
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases