Assessing Interventions of Diet in IBD

Not Applicable

Recruiting

• Conditions: IBD (Inflammatory Bowel Disease); Ulcerative Colitis (UC); Crohn Disease (CD)

• Registration Number: NCT06773182
• Lead Sponsor: McMaster University

Brief Summary

In this study, we are trying to learn how certain diets affect people with inflammatory bowel disease (IBD). We want to understand what makes it hard or easy for them to stick to different eating plans, like intermittent fasting, the Mediterranean diet, and the Low FODMAP diet. By finding out how these diets help with symptoms and which ones are easier to follow, we hope to improve the quality of life for people with IBD.

Detailed Description

This study aims to explore the impact of specific dietary interventions on individuals living with inflammatory bowel disease (IBD). By examining dietary patterns such as intermittent fasting, the Mediterranean diet, and the Low FODMAP diet, we seek to identify barriers to adherence and facilitators that make these eating plans sustainable. Additionally, we aim to evaluate the perceived benefits of these diets in managing IBD symptoms and their influence on overall quality of life. The findings will provide valuable insights to develop patient-centered nutritional strategies that enhance adherence and therapeutic outcomes in IBD care.

Study Timeline

• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-14
• Study Start: 2025-04-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-23
• Last Update Posted: 2025-06-26
• Primary Completion: 2026-04-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Adults (18+ years) diagnosed with ulcerative colitis or Crohn's disease.
• Having willingness to use their personal smartphone to access the app
• Able to understand the indication by the registered dietitian.
• Able to provide informed consent.
• Willingness to attempt intervention diet and commit to study procedures.

Exclusion Criteria

• Pregnant women.
• Currently being treated for eating disorders, schizophrenia, psychosis, or other acute mental disorders.
• Currently being treated for chemotherapy.
• Diabetes
• Advance chronic kidney disease
• Short bowl syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To identify IBD's top three patients' barriers to access and follow the nutritional intervention.	From enrollment to the end of the study and at 5 weeks	The outcome will be assessed through semi-structured one-on-one interviews conducted at the end of the study. Interviews will last approximately 40 minutes to 1 hour and will follow a structured interview guide with open-ended questions, designed to explore participants' experiences, perceptions, and challenges in accessing and adhering to the nutritional intervention. Interviews will be audio-recorded and transcribed verbatim.; Data will be analyzed using thematic analysis informed by interpretive description methodology, to identify key personal and systemic barriers. NVivo software (QSR International) will be used to facilitate qualitative coding and analysis.

Secondary Outcome Measures

Name	Time	Method
To identify adherence to each food intervention through the use of an app (RxFood) and different questionnaires.	From enrollment to the end of the study and at 5 weeks
To identify specific sociodemographic criteria that may act as a deterrent or facilitator in the ability to generate honest qualitative data through questionnaires and an individual interview.	From enrollment to the end of the study and at 5 weeks

Trial Locations

Locations (2)

2F Digestive Diseases Clinic - Hamilton Health Science; 🇨🇦 Hamilton, Ontario, Canada

McMaster University; 🇨🇦 Hamilton, Ontario, Canada