Assessing Interventions of Diet in IBD

NCT06773182 | Recruiting

• 1 other identifier: REB #18028
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

IBD; Low FODMAP Diet; Mediterranean diet; Intermittent fasting; Ulcerative colitis; Crohn's disease

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• 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

• 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

Study Arms (3)

Intermittent Fasting

EXPERIMENTAL

Participants will be assigned to follow an intermittent fasting protocol.

Mediterranean Diet

EXPERIMENTAL

Participants will be assigned to follow a Mediterranean diet.

Low FODMAP Diet

EXPERIMENTAL

Participants will be assigned to follow a Low FODMAP Diet.

Other: Low FODMAP Diet Intervention

Interventions

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.

Low FODMAP Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (3)

2F Digestive Diseases Clinic - Hamilton Health Science

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

NOT YET RECRUITING

McMaster University

Hamilton, Ontario, L8S 4K1, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease; Intermittent Fasting

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases; Fasting; Feeding Behavior; Behavior

Central Study Contacts

Camila Pettinari, Bacherol

CONTACT

4168271741; pettinaricamila@gmail.com

Vanina Noejovich, PhD

CONTACT

19055318461; noejovcv@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a mixed-design, randomized, parallel-group trial with three independent arms. Participants will be randomly assigned to one of three dietary intervention groups: intermittent fasting, the Mediterranean diet, or the Low FODMAP diet. Each arm will operate independently, and participants will adhere exclusively to their assigned dietary intervention throughout the study duration. The design ensures that the effects of each diet are evaluated in isolation, allowing for a direct comparison of adherence rates, perceived benefits, and impacts on IBD symptom management across the groups.

Study Record Dates

• First Submitted: January 8, 2025
• First Posted: January 14, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available after data completion - estimated 1 year
• Access Criteria: The research team who will evaluate the interventions of diet in IBD

Locations

CA (3)