Crohn Disease (CD), IBD (Inflammatory Bowel Disease), Ulcerative Colitis (UC)
Conditions
Keywords
IBD, Low FODMAP Diet, Mediterranean diet, Intermittent fasting, Ulcerative colitis, Crohn's disease
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.
Interventions
OTHERIntermittent 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.
A diet emphasizing whole grains, fruits, vegetables, olive oil, lean proteins, and minimizing processed foods.
A diet limiting fermentable oligosaccharides, disaccharides, monosaccharides, and polyols to manage gastrointestinal symptoms.
Sponsors
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To identify IBD's top three patients' barriers to access and follow the nutritional intervention. | 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. |
Secondary
| 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. | 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 |
Countries
Canada
Outcome results
None listed