Assessing Interventions of Diet in IBD (AID-IBD)

June 23, 2025 updated by: David Armstrong, McMaster University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4K1
        • Not yet recruiting
        • McMaster University
        • Contact:
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • 2F Digestive Diseases Clinic - Hamilton Health Science
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent Fasting
Participants will be assigned to follow an intermittent fasting protocol.
Other: Intermittent Fasting Intervention
A 14:10 intermittent fasting regimen, where participants fast for 14 hours and consume all meals within a 10-hour eating window daily.
Experimental: Mediterranean Diet
Participants will be assigned to follow a Mediterranean diet.
Other: Mediterranean Diet Intervention
A diet emphasizing whole grains, fruits, vegetables, olive oil, lean proteins, and minimizing processed foods.
Experimental: Low FODMAP Diet
Participants will be assigned to follow a Low FODMAP Diet.
Other: Low FODMAP Diet Intervention
A diet limiting fermentable oligosaccharides, disaccharides, monosaccharides, and polyols to manage gastrointestinal symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of the study and at 5 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From enrollment to the end of the study and at 5 weeks
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
From enrollment to the end of the study and at 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 8, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 23, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB #18028

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Approach investigators to ask for anonymized dataset

IPD Sharing Time Frame

Data will be available after data completion - estimated 1 year

IPD Sharing Access Criteria

The research team who will evaluate the interventions of diet in IBD

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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