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NCT Number: NCT06356220

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

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

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Key information

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location status: Recruiting

Location contact

Lauren Robertson

CONTACT

[email protected]

617-355-6000

Nan Du, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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. .

Primary outcomes

  1. To compare the effect of GFFG versus conventional GFD class on body composition, specifically fat free mass

    Time frame: Over 6 months

    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

Secondary outcomes

  1. To compare the effect of GFFG vs conventional GFD class on diet quality

    Time frame: Over 6 months

    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.

  2. To compare the effect of GFFG versus conventional GFD on arsenic exposure

    Time frame: Over 6 months

    The outcome is nail arsenic level after six months on GFD. Toenails will be stored at room temperature and are stable as heavy metals naturally bind to keratin. Toenails will be cleaned to remove exogenous contamination, and then, acid digested.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Acronym: GF-NOURISH

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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