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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorBoston Children's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Allergic to <3 of the top 8 food allergens

Co-morbid conditions treated with dietary modifications or that influence nail arsenic values

Trial design

Design model

Parallel

Treatments tested in this trial

  • Gluten-Free Diet Education

    Other intervention

    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. .

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: GFFGExperimental treatment 1 intervention
Group B: Conventional GFD Nutrition EducationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Over 6 months

Secondary outcomes

1

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.

Time frame
Over 6 months
2

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

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.

Time frame
Over 6 months

Other outcomes

Sponsors and contacts

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