Assessing Interventions of Diet in IBD

NCT ID: NCT06773182

Last Updated: 2025-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2027-01-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intermittent Fasting

Participants will be assigned to follow an intermittent fasting protocol.

Group Type EXPERIMENTAL

No interventions assigned to this group

Mediterranean Diet

Participants will be assigned to follow a Mediterranean diet.

Group Type EXPERIMENTAL

No interventions assigned to this group

Low FODMAP Diet

Participants will be assigned to follow a Low FODMAP Diet.

Group Type EXPERIMENTAL

Low FODMAP Diet Intervention

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Mediterranean Diet Intervention

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

Intervention Type OTHER

Low FODMAP Diet Intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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David Armstrong

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2F Digestive Diseases Clinic - Hamilton Health Science

Hamilton, Ontario, Canada

Site Status RECRUITING

McMaster University

Hamilton, Ontario, Canada

Site Status NOT_YET_RECRUITING

McMaster University

Hamilton, Ontario, Canada

Site Status NOT_YET_RECRUITING

Countries

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Canada

Central Contacts

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Camila Pettinari, Bacherol

Role: CONTACT

4168271741

Vanina Noejovich, PhD

Role: CONTACT

19055318461

Facility Contacts

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David Armstrong Dr.

Role: primary

905-525-9140 ext. 76404

Camila Pettinari, Bacherol

Role: primary

4168271741

Vanina Noejovich, PhD

Role: backup

19055318461

Camila Pettinari, Bacherol

Role: primary

4168271741

Other Identifiers

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REB #18028

Identifier Type: -

Identifier Source: org_study_id

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