Gluten-Free Diet Guidance for Celiac Disease

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Type 1 diabetes, others

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

Compensation: Varies

Number of Visits: 1

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new gluten-free food guide to determine if it helps kids and teens with celiac disease improve their diets. Celiac disease is an autoimmune condition where gluten consumption harms the small intestine. The study compares traditional dietary advice with this new guide to assess whether it enhances diet quality and adherence to a gluten-free diet over six months. Kids and teens diagnosed with celiac disease within the last three months may be suitable candidates. Participants will engage in a 45-minute dietary counseling session via Zoom. As an unphased trial, this study provides a unique opportunity to contribute to innovative dietary solutions for celiac disease.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this gluten-free food guide is safe for children with celiac disease?

Research has shown that a gluten-free diet is safe for people with celiac disease. This diet involves avoiding foods containing gluten, a protein found in wheat, barley, and rye. Studies indicate that consuming gluten-free foods helps prevent issues like anemia, weak bones, and other serious health problems in those with celiac disease.

The gluten-free food guide tested in the trial is based on this established diet. It aims to help people follow the diet more easily and make better food choices. Since the guide builds on an already safe diet, it should be well-tolerated. No reports have indicated negative effects from using a gluten-free food guide for dietary advice.

In summary, a gluten-free diet is considered safe for those with celiac disease, and the gluten-free food guide aims to make following the diet easier and healthier. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces a novel gluten-free food guide that offers personalized dietary guidance for people with celiac disease. Unlike the standard approach, which generally covers basic gluten-free diet education, this new method provides a tailored 45-minute one-on-one session focusing on the GF plate model and individual dietary needs. This personalized approach aims to improve dietary adherence and overall health outcomes by addressing specific nutritional gaps and preferences, making it a potentially more effective strategy for managing celiac disease.

What evidence suggests that the gluten-free food guide teaching is effective for improving diet quality and adherence to a gluten-free diet in children with celiac disease?

Studies have shown that the only effective treatment for celiac disease is a gluten-free diet (GFD). However, maintaining this diet can be challenging, especially for children. Research indicates that gluten-free diets often lack important nutrients like iron and calcium and can lead to higher sugar and fat intake. In this trial, one group of participants will receive the new gluten-free food guide (GFFG) as part of their dietary counseling. This guide aims to improve diet quality by addressing these issues. Early findings suggest that similar nutrition education programs have helped people with celiac disease better understand their diet and improve their eating habits. This guide could be a useful tool to help people adhere to the gluten-free diet and enhance their overall nutrition. ^{6 7 8 9 10}

Who Is on the Research Team?

Diana R Mager

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for children and adolescents aged 5-18 with a recent diagnosis of celiac disease within the last 3 months. Their parents are also involved. It's not suitable for those under 5, diagnosed over 3 months ago, with type 1 diabetes, or without a clinical diagnosis of celiac disease.

Inclusion Criteria

You were diagnosed with the condition within the last 3 months.

I have been diagnosed with celiac disease by a doctor.

Exclusion Criteria

I was diagnosed with celiac disease more than 3 months ago.

I am a child or teenager diagnosed with type 1 diabetes.

I have not been diagnosed with celiac disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dietary counselling using the gluten-free food guide or standard of care over six months

24 weeks

1 visit (virtual) for dietary counselling

Follow-up

Participants are monitored for diet quality, nutrition literacy, and adherence to the gluten-free diet

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gluten-free food guide teaching

Trial Overview The study tests if teaching about a Gluten-Free Food Guide can improve diet quality and adherence to a gluten-free diet in youth with celiac disease compared to standard dietary counseling.

How Is the Trial Designed?

Group I: Standard of Care + Gluten-free food guide teaching Experimental Treatment 1 Intervention

45-minute dietary counselling session using the novel gluten-free food guide conducted by a researcher over Zoom. This occurs after standard of care dietary education by an RD. The gluten free teaching session in the study protocol focuses on the GF plate model, the rationale for the GF plate model, and addressing the individual participants dietary needs based on a dietary intake assessment by a trained investigator using specific educational materials that are present in the guide.

Group II: Standard of Care Active Control 1 Intervention

45-minute group session on the gluten-free diet conducted by registered dietitians over Zoom. The registered dietitian's dietary education included a virtual group class focusing on gluten literacy, meal planning, food label reading and dietary intake based on Canada's Food Guide to Healthy Eating (2019).

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06038344

Influence of a Gluten Free Food Guide on Diet Quality and ... This randomized clinical trial aims to evaluate the impact of GFFG on diet quality and adherence to the GFD in newly diagnosed children and youth with celiac ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10537989/

The Gluten-Free Diet for Celiac Disease: Critical Insights to ... In general, gluten-free raw food sources have fewer minerals such as iron, calcium, and magnesium, and industrial food processing may reduce the micronutrient ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0010482524015907

Effectiveness of a nutrition education programme for ... GLUTLEARN has been found to be effective in improving the knowledge of people with CD and their supporters and improving attitudes among individuals.

4. celiac.org celiac.org/wp-content/uploads/2020/05/Celiac-Disease-School-Management-Plan.pdf

MANAGING CELIAC DISEASE IN LEARNING ... This is the first study to examine gluten exposure during common educational activities and it provides useful data to help guide assessment of risk of cross- ...

5. bmcgastroenterol.biomedcentral.com bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-025-04193-3

Gluten-free diet adherence patterns and health outcomes in ... The only effective treatment is a gluten-free diet (GFD), but adherence can be challenging. This study investigates GFD adherence among CeD ...

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

Gluten-free diet A gluten-free diet is an eating plan that cuts out foods that have a protein in them called gluten. Gluten helps foods keep their shape.

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

The Gluten-Free Diet for Celiac Disease and Beyond - PMC Therefore, eating foods that have a gluten-free label is generally a safe option for avoiding gluten-contaminated food. Finally, adhering to a ...

8. 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.

9. academic.oup.com academic.oup.com/nutritionreviews/advance-article/doi/10.1093/nutrit/nuaf069/8152198?searchresult=1

Gluten-Free Diet in the Context of Food and Nutrition Security ... A gluten-free diet (GFD) is the only safe treatment for people with gluten-related disorders (GRDs). However, adherence to a GFD is ...

10. mdpi.com mdpi.com/2072-6643/17/12/1956

Celiac Disease and Gluten-Free Diets: A Path or Barrier to ... Gluten ingestion with CD may cause several critical manifestations and adverse outcomes such as anemia, osteoporosis, cancer, infertility, liver disease, ...