Assessing Interventions of Diet in IBD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcMaster University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant women.
Currently being treated for eating disorders, schizophrenia, psychosis, or other acute mental disorders.
Currently being treated for chemotherapy.
Diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Intermittent Fasting Intervention
Other interventionA 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 interventionA diet emphasizing whole grains, fruits, vegetables, olive oil, lean proteins, and minimizing processed foods.
Low FODMAP Diet Intervention
Other interventionA diet limiting fermentable oligosaccharides, disaccharides, monosaccharides, and polyols to manage gastrointestinal symptoms.
Treatment groups
45 Participants
are divided into 3 treatment groupsGroup A: Intermittent FastingExperimental treatment 0 interventions
Group B: Mediterranean DietExperimental treatment 0 interventions
Group C: Low FODMAP DietExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
From enrollment to the end of the study and at 5 weeksSecondary outcomes
1
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.
Time frame
From enrollment to the end of the study and at 5 weeks2
To identify adherence to each food intervention through the use of an app (RxFood) and different questionnaires.
Time frame
From enrollment to the end of the study and at 5 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov