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Completed

NCT Number: NCT06773182

Assessing Interventions of Diet in IBD

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.

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Key information

Conditions

IBD (Inflammatory Bowel Disease) Behavior Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Crohn Disease (CD) Digestive System Diseases Fasting Feeding Behavior Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intermittent Fasting Intestinal Diseases Ulcerative Colitis (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Fasting Intervention

Other

A 14:10 intermittent fasting regimen, where participants fast for 14 hours and consume all meals within a 10-hour eating window daily.

Mediterranean Diet Intervention

Other

A diet emphasizing whole grains, fruits, vegetables, olive oil, lean proteins, and minimizing processed foods.

Low FODMAP Diet Intervention

Other

A diet limiting fermentable oligosaccharides, disaccharides, monosaccharides, and polyols to manage gastrointestinal symptoms.

Primary outcomes

  1. To identify IBD's top three patients' barriers to access and follow the nutritional intervention.

    Time frame: 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 outcomes

  1. 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.

    Time frame: From enrollment to the end of the study and at 5 weeks

  2. To identify adherence to each food intervention through the use of an app (RxFood) and different questionnaires.

    Time frame: From enrollment to the end of the study and at 5 weeks

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

Understanding Patient's Barriers and Perceived Benefits Through Adherence to Nutritional Interventions in IBD: a Preliminary Study.

Acronym: AID-IBD

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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