Clinical trial NCT06773182: Assessing Interventions of Diet in IBD
Official title: Understanding Patient's Barriers and Perceived Benefits Through Adherence to Nutritional Interventions in IBD: a Preliminary Study.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: IBD (Inflammatory Bowel Disease)
Ulcerative Colitis (UC)
Crohn Disease (CD)
Keywords: IBD
Low FODMAP Diet
Mediterranean diet
Intermittent fasting
Ulcerative colitis
Crohn&#39;s disease
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To identify IBD's top three patients' barriers to access and follow the nutritional intervention.
timeFrame: From enrollment to the end of the study and at 5 weeks
Secondary outcomes:
measure: 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.
timeFrame: From enrollment to the end of the study and at 5 weeks
measure: To identify adherence to each food intervention through the use of an app (RxFood) and different questionnaires.
timeFrame: From enrollment to the end of the study and at 5 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References: