40 Participants Needed

Gluten-Free Diet Guidance for Celiac Disease

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Celiac disease (CD) is an autoimmune gastrointestinal disease that is caused by intolerance to gluten in the diet. The mainstay of treatment is a gluten-free diet (GFD). Children with CD on the GFD often have low micronutrient intakes (e.g. folate, iron) and high intakes of sugar and fat. Current Canadian nutrition guideline does not address these nutritional limitations. The investigation team developed a novel GF-food guide (GFFG). 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 disease in the clinical setting. The investigators will compare dietary counselling using the GFFG versus the standard of care in children newly diagnosed with CD and their parents to see if participant care outcomes (diet quality, nutrition literacy, adherence to the GFD) improved over six months.

Who Is on the Research Team?

DR

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.
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care + Gluten-free food guide teachingExperimental Treatment1 Intervention
Group II: Standard of CareActive Control1 Intervention

Find a Clinic Near You

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+
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