IBD (Inflammatory Bowel Disease)AID-IBDNCT06773182
Assessing Interventions of Diet in IBD
A study testing Intermittent Fasting Intervention, Mediterranean Diet Intervention and Low FODMAP Diet Intervention in people with IBD (Inflammatory Bowel Disease) and Ulcerative Colitis (UC), run by McMaster University at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), Ulcerative Colitis (UC), Crohn Disease (CD)
- What is being tested?
- Intermittent Fasting Intervention, Mediterranean Diet Intervention and Low FODMAP Diet Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Apr 2025to 5 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
2F Digestive Diseases Clinic - Hamilton Health Science
Hamilton, Ontario, L8N 3Z5
McMaster University
Hamilton, Ontario, L8S 4K1
About this study
Official title: Understanding Patient's Barriers and Perceived Benefits Through Adherence to Nutritional Interventions in IBD: a Preliminary Study.
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.
Read the 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.
- Being tested
- Intermittent Fasting Intervention, Mediterranean Diet Intervention, Low FODMAP Diet Intervention
- Keywords
- IBD, Low FODMAP Diet, Mediterranean diet, Intermittent fasting, Ulcerative colitis, Crohn's disease
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent Fasting InterventionOther
A 14:10 intermittent fasting regimen, where participants fast for 14 hours and consume all meals within a 10-hour eating window daily.
Mediterranean Diet InterventionOther
A diet emphasizing whole grains, fruits, vegetables, olive oil, lean proteins, and minimizing processed foods.
Low FODMAP Diet InterventionOther
A diet limiting fermentable oligosaccharides, disaccharides, monosaccharides, and polyols to manage gastrointestinal symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Fasting | Experimental | Participants will be assigned to follow an intermittent fasting protocol. |
| Mediterranean Diet | Experimental | Participants will be assigned to follow a Mediterranean diet. |
| Low FODMAP Diet | Experimental | Participants will be assigned to follow a Low FODMAP Diet. Receives: Other: Low FODMAP Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of the study and at 5 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: From enrollment to the end of the study and at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Apr 2025
- Primary completion1 Apr 2026
- Study completion5 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Armstrong, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773182
- Sponsor's protocol ID
- REB #18028
- Acronym
- AID-IBD
- Status last verified
- Jul 2026
- First submitted
- 8 Jan 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Approach investigators to ask for anonymized dataset
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Patient's Barriers and Perceived Benefits Through Adherence to Nutritional Interventions in IBD: a Preliminary Study.
- ClinicalTrials.gov ID
- NCT06773182
- Acronym / sponsor ID
- AID-IBD / REB #18028
- Keywords
- IBD, Low FODMAP Diet, Mediterranean diet, Intermittent fasting, Ulcerative colitis, Crohn's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 5 Jul 2026 (actual)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intermittent Fasting | Experimental | –Participants will be assigned to follow an intermittent fasting protocol. |
| Mediterranean Diet | Experimental | –Participants will be assigned to follow a Mediterranean diet. |
| Low FODMAP Diet | Experimental | Other: Low FODMAP Diet InterventionParticipants will be assigned to follow a Low FODMAP Diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittent Fasting InterventionA 14:10 intermittent fasting regimen, where participants fast for 14 hours and consume all meals within a 10-hour eating window daily. | Other | – |
| Mediterranean Diet InterventionA diet emphasizing whole grains, fruits, vegetables, olive oil, lean proteins, and minimizing processed foods. | Other | – |
| Low FODMAP Diet InterventionA diet limiting fermentable oligosaccharides, disaccharides, monosaccharides, and polyols to manage gastrointestinal symptoms. | Other | Low FODMAP Diet |
Primary outcome
To identify IBD's top three patients' barriers to access and follow the nutritional intervention.
Time frame: 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.
2 secondary outcomes
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 weeks
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 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: Yes. Approach investigators to ask for anonymized dataset
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittent Fasting Intervention, Mediterranean Diet Intervention and Low FODMAP Diet Intervention in people with IBD (Inflammatory Bowel Disease) and Ulcerative Colitis (UC), run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify IBD's top three patients' barriers to access and follow the nutritional intervention. (time frame: From enrollment to the end of the study and at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.