Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06773182

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

Led by McMaster University · Updated on 2025-06-26

45

Participants Needed

3

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how different diets affect people with inflammatory bowel disease (IBD), including ulcerative colitis and Crohn's disease. The study aims to understand what makes it easier or harder for individuals to follow eating plans like intermittent fasting, the Mediterranean diet, and the Low FODMAP diet. By learning about the benefits and challenges of these diets, the study hopes to improve the quality of life for those living with IBD. Participants will be randomly assigned to follow one of three dietary plans: a 14:10 intermittent fasting schedule where meals are eaten within a 10-hour window daily, a Mediterranean diet rich in whole grains, fruits, vegetables, olive oil, and lean proteins while limiting processed foods, or a Low FODMAP diet that restricts certain carbohydrates to manage gut symptoms. Each participant will use a smartphone app to help track their dietary adherence and will receive guidance from a registered dietitian. Throughout the study, participants will complete questionnaires and interviews to identify barriers to sticking with the diets and to assess perceived benefits. Researchers will monitor adherence using the app and surveys over the course of the study. The main outcome is to identify the top three barriers patients face in accessing and following these diets. The study will also explore how sociodemographic factors influence honest reporting and adherence. Participation involves ongoing assessments from enrollment until five weeks later, with safety and quality of life being monitored.

CONDITIONS

Brief Title

Assessing Interventions of Diet in IBD

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older diagnosed with ulcerative colitis or Crohn's disease
  • Willing to use their personal smartphone to access the study app
  • Able to understand dietary guidance from a registered dietitian
  • Able to provide informed consent
  • Willing to try the assigned diet and follow study procedures
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Currently treated for eating disorders, schizophrenia, psychosis, or other acute mental disorders
  • Currently receiving chemotherapy treatment
  • Diagnosed with diabetes
  • Having advanced chronic kidney disease
  • Having short bowel syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or virtual) for eligibility assessment and informed consent

Treatment

Duration - 5 weeks

Participants follow one of three assigned dietary interventions: intermittent fasting, Mediterranean diet, or Low FODMAP diet, guided by dietary counseling and monitored through an app and questionnaires.

Initial baseline visit and weekly remote check-ins via app for adherence and support

Trial Site Locations

Total: 3 locations

1

2F Digestive Diseases Clinic - Hamilton Health Science

Hamilton, Ontario, Canada, L8N 3Z5

Actively Recruiting

2

McMaster University

Hamilton, Ontario, Canada, L8S 4K1

Not Yet Recruiting

3

McMaster University

Hamilton, Ontario, Canada, L8S 4K1

Not Yet Recruiting

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Research Team

C

Camila Pettinari, Bacherol

V

Vanina Noejovich, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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