Gluten-Free Diet Education for Celiac Disease

(GF-NOURISH Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Food allergies, Dietary conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special gluten-free diet education program can improve the health of children with celiac disease. The program emphasizes naturally gluten-free foods while reducing ultra-processed gluten-free options. Participants will either follow this new educational approach or receive conventional gluten-free diet advice. Children aged 2 to 18 years with a recent celiac disease diagnosis are suitable candidates for this trial. As an unphased trial, it offers a unique opportunity for participants to contribute to innovative dietary education that could enhance the well-being of children with celiac disease.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this nutritional education program is safe?

Research has shown that a gluten-free diet is generally safe for people with celiac disease, provided they avoid foods labeled "gluten removed" or "processed to remove gluten," which are unsafe for them. Consuming foods with a "gluten-free" label reliably prevents gluten contamination.

Studies have found that people with celiac disease can safely consume up to 30 mg of gluten per day without adverse effects. Thus, a well-managed gluten-free diet can effectively control celiac symptoms.

The GF-NOURISH study focuses on nutrition education, emphasizing natural gluten-free foods and reducing processed ones. This approach is designed to be safe and aims to improve health by increasing the intake of plant proteins, fruits, and vegetables.

Overall, gluten-free diet education appears well-received, emphasizing safety and health benefits for those with celiac disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Gluten-Free-Food Guide (GFFG) because it goes beyond typical gluten-free diet education by focusing on the quality of the foods consumed. Unlike standard gluten-free diet (GFD) education, which often emphasizes avoiding gluten, the GFFG aims to improve overall nutrition by encouraging the consumption of natural, minimally processed gluten-free foods and increasing intake of plant proteins, fruits, and vegetables. This approach not only helps manage celiac disease but also promotes better general health, setting it apart from conventional methods.

What evidence suggests that this nutritional education program is effective for celiac disease?

Studies have shown that a strict gluten-free diet (GFD) is the only effective treatment for celiac disease. Research indicates that following a GFD can heal the small intestine in about 95% of people with celiac disease. In this trial, participants will receive either the Gluten Free-Food Guide (GFFG) intervention or conventional GFD nutrition education. The GFFG, used in diet education, has improved diet quality in children who are newly diagnosed. While a GFD is essential for managing celiac disease, it can be complicated, and proper education can help. Guidance can increase the intake of naturally gluten-free foods, improving overall nutrition. However, balancing the diet is important to maintain a good quality of life, as a GFD can sometimes affect social and emotional well-being. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with Celiac Disease who may also be dealing with malnutrition or other nutrition disorders. The key eligibility criteria are not fully listed, but participants would typically need to have a confirmed diagnosis of Celiac Disease and possibly face nutritional challenges.

Exclusion Criteria

Allergic to less than 3 of the top 8 food allergens

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutritional education focused on minimizing ultra-processed gluten-free foods or conventional GFD education

6 months

Regular visits for educational sessions

Follow-up

Participants are monitored for changes in body composition, diet quality, and arsenic exposure after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gluten-Free Diet Education

Trial Overview The GF-NOURISH study is testing the effectiveness of a nutritional education program that emphasizes natural gluten-free foods while reducing ultra-processed gluten-free options. It aims to show how this approach can lead to better health outcomes for those with Celiac Disease.

How Is the Trial Designed?

Group I: GFFG Experimental Treatment 1 Intervention

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.

Group II: Conventional GFD Nutrition Education Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

TEACH Kitchen, a student-led initiative at the Medical College of Georgia, aims to improve nutrition education and healthy cooking skills among patients with chronic diseases, addressing a significant gap in healthcare.

The program has enrolled 14 patients and 6 children, focusing on modules related to obesity, hypertension, hyperlipidemia, and diabetes, with the goal of measuring improvements in knowledge and clinical indicators like body mass index and blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TEACH Kitchen: A Chronological Review of Accomplishments. Chae, JH., Ansa, BE., Smith, SA.[2020]

Children with celiac disease who were lost to follow-up (LTFU) showed significantly poorer adherence to a gluten-free diet (GFD), with an average Biagi score of 2.0 compared to 3.0 in those who regularly followed up, indicating a need for better monitoring and support.

LTFU patients had a higher prevalence of positive celiac serology tests (50% vs. 25% in controls), suggesting that non-adherence to the GFD is linked to worse health outcomes, and factors such as older age at diagnosis and lack of membership in celiac associations contribute to this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric celiac disease patients who are lost to follow-up have a poorly controlled disease. Barnea, L., Mozer-Glassberg, Y., Hojsak, I., et al.[2015]

Citations

1. cambridge.org cambridge.org/core/product/5F5BD3F5629568BB445CEC989384E260

A Gluten Free Food Guide Used in Diet Education to ... A Gluten Free Food Guide Used in Diet Education to Improve Diet Quality in Children with Newly Diagnosed Celiac Disease: A Pilot Randomized Control Trial.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8625243/

The Gluten-Free Diet for Celiac Disease and Beyond - PMC There has been extensive research on the efficacy of the GFD. A strict GFD can restore the histology of the small bowel architecture in 95% of ...

3. gastrojournal.org gastrojournal.org/article/s0016-5085(05)00189-7/fulltext

The gluten-free diet: How to provide effective education ... A strict gluten-free diet (GFD) for life is the only treatment for celiac disease (CD). This article reviews (1) the impact of the GFD on the quality of life ...

4. mdpi.com mdpi.com/2072-6643/15/18/4013

The Gluten-Free Diet for Celiac Disease: Critical Insights to ... Currently, following a lifelong GFD is the only effective CeD treatment. Although notionally simple, the GFD has many complexities and it should be not only ...

5. celiac.org celiac.org/2018/03/05/gluten-free-diet-quality-life/

Gluten-Free Diet and Quality of Life This study found that strict adherence to a gluten-free diet can actually lower quality of life for celiac disease patients, when social and emotional factors ...

6. mayoclinic.org mayoclinic.org/healthy-lifestyle/nutrition-and-healthy-eating/in-depth/gluten-free-diet/art-20048530

Gluten-free diet But those labeled "gluten removed" or "processed to remove gluten" are not safe for people with celiac disease. Processed foods that often have gluten in them.

7. celiac.org celiac.org/gluten-free-living/gluten-free-foods/

Gluten-Free Foods The most cost-effective and healthy way to follow the gluten-free diet is to seek out these naturally gluten-free food groups.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7069540/

Celiac disease and gluten-free diet: past, present, and future According to Collin et al. (10), 30 mg of gluten per day is safe for celiac patients. Catassi et al. (11) performed tests on 49 patients (37 ...

9. youtube.com youtube.com/watch?v=Q7j0DAdOm0A

Celiac Disease: Getting Started on Gluten Free Diet Learn the basics of a gluten free diet from the experts in the Celiac Disease Program at Children's National Hospital.