Diet, HealthyNCT05566587
Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset
A study testing Mediteranean to Western to Mediteranean Diet and Western to Mediteranean to Western Diet in people with Diet, Healthy and High Risk, run by Mount Sinai Hospital, Canada.
Trial summary
The purpose of this trial is to run a pilot study that examines the impact of different dietary components on risk factors such as the Genetic, Environmental, Microbial (GEM) Microbiome Risk Score (GMRS) and fecal calprotectin (FCP), a marker of inflammation in the bowels, and a risk factor for developing Crohn's… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, Healthy, High Risk
- What is being tested?
- Mediteranean to Western to Mediteranean Diet and Western to Mediteranean to Western Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Mar 2024
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, asymptomatic first degree relative (child or sibling) of someone with Crohn's disease
- Have at least 1 bowel movement every other day
Who cannot join
- Received antibiotic treatment within 3 months of recruitment
- Unintentional weight loss in the last 3 months more than 15% of baseline weight
- Have ever been diagnosed with any chronic or recurring gastro-intestinal disease or bowel disease
- Belly pain occurred more than once per week for longer than three months in the past year
- Diarrhea (>three times per day) has been occurring for more than three months in the last year
- Have blood in their stool with most stools
Show all 15Show fewer
- Diagnosed with diabetes
- Diagnosed with Celiac disease
- Diagnosed with irritable bowel syndrome
- Diagnosed with inflammatory bowel disease
- Presents significant symptoms of gastrointestinal disease
- Pregnant or breastfeeding women
- Has any serious food allergies
- Diagnosed with lactose intolerance
- Unable to stop NSAID or probiotic use during the study
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this trial is to run a pilot study that examines the impact of different dietary components on risk factors such as the Genetic, Environmental, Microbial (GEM) Microbiome Risk Score (GMRS) and fecal calprotectin (FCP), a marker of inflammation in the bowels, and a risk factor for developing Crohn's disease (CD) among first degree relatives (parents, siblings, or offspring) of Crohn's patients. The study will utilize the Western diet and the Mediterranean diet to explore the complex interplay between diet, microbiome, and inflammatory biomarkers to identify specific dietary components that may be beneficial in reducing the risk of developing CD. The study will enroll 30 participants from Mount Sinai Hospital in Toronto.
Read the detailed description
This study is a clinical trial that will occur at Mount Sinai Hospital and healthy first degree relatives of CD patients will be recruited. Participation will occur over 7 weeks with 1 week of consuming the subject's regular diet and 6 weeks of intervention. A total of 30 subjects are expected to be enrolled into this trial. As part of this trial, The study will attempt to modify dietary consumption between the Western Diet (WD) and the Mediterranean Diet (MD) to evaluate participants responses to specific food items key to the WD or MD by monitoring subject's GMRS and FCP. Subjects will be randomized into one of two groups (1:1), in which there will be crossover between the two diets. Stool samples will be collected 3 times a week, a daily questionnaire and a daily consumption diary will be completed through an app.
Group 1 will follow the WD for weeks 2 and 3, switch to the MD for weeks 4 and 5, and then back to the WD for weeks 6 and 7. Group 2 will follow the MD for weeks 2 and 3, switch to the WD for weeks 4 and 5, and then back to the MD for weeks 6 and 7.
Meal plans developed by the study Dietitian and recipes will be provided for all weeks of the intervention (weeks 2-7). These meal plans will be identical for subjects within the same group. Groceries required to prepare the meals as per the meal plan will be provided to subjects on a weekly basis.
- Conditions
- Diet, Healthy, High Risk
- Being tested
- Mediteranean to Western to Mediteranean Diet, Western to Mediteranean to Western Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mediteranean to Western to Mediteranean DietOther
week 2-3 : Switching between Mediterranean diet and Western diet week 4-5 : Switching between Western diet and Mediterranean diet week 6-7 : Switching between Mediterranean diet and Western diet
Western to Mediteranean to Western DietOther
week 2-3 : Switching between Western diet and Mediterranean diet week 4-5 : Switching between Mediterranean diet and Western diet week 6-7 : Switching between Western diet and Mediterranean diet
| Study group | Role | What they receive |
|---|---|---|
| Western to Mediteranean to Western Diet | Other | Weeks 2 and 3 = WD Weeks 4 and 5 = MD Weeks 6 and 7 = WD Receives: Other: Mediteranean to Western to Mediteranean Diet; Other: Western to Mediteranean to Western Diet |
| Mediteranean to Western to Mediteranean Diet | Other | Weeks 2 and 3 = MD Weeks 4 and 5 = WD Weeks 6 and 7 = MD Receives: Other: Mediteranean to Western to Mediteranean Diet; Other: Western to Mediteranean to Western Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personalized model
Repeated measures of FCP and GMRS will be used to generate a personalized model identifying food items that provide are predicted to have the greatest effect in the GMRS and FCP levels for a given individual
Measured: 7 weeks
Secondary outcomes (5)
Concentration of FCP levels over time during each intervention
fecal calprotectin will be analyzed from all stool samples collected during the study to provide continual data on any changes in intestinal inflammation
Measured: Duration of each diet (2 to 4 weeks)
Modulation of GMRS over time during each intervention
Microbiome data will be collected from all stool samples collected during the study to provide continual data on any changes. This data will be used to calculate the GMRS at each time point. A higher GMRS indicate high risk for Crohn's disease
Measured: Duration of each diet (2 to 4 weeks)
Measure of microbial taxa relative abundance over time during each intervention
Microbiome data will be collected from all stool samples collected during the study to provide continual data on any changes in microbial composition
Measured: Duration of each diet (2 to 4 weeks)
Ability to maintain a balanced diet as measured by food intake records
Through the submission of the daily food diaries an assessment on the ability to maintain the diet will be reviewed
Measured: 6 weeks
Adherence to the interventions
Compliance to the diet will be monitored through an app throughout the study
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study startOct 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ken Croitoru, Mount Sinai Hospital, Canada
- Investigators
- Kenneth Croitoru, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566587
- Sponsor's protocol ID
- POP21-10037
- Status last verified
- Oct 2022
- First submitted
- 16 Sep 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset
- ClinicalTrials.gov ID
- NCT05566587
- Acronym / sponsor ID
- POP21-10037
- Conditions
- Diet, Healthy, High Risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 4 Oct 2022 (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.
The purpose of this trial is to run a pilot study that examines the impact of different dietary components on risk factors such as the Genetic, Environmental, Microbial (GEM) Microbiome Risk Score (GMRS) and fecal calprotectin (FCP), a marker of inflammation in the bowels, and a risk factor for developing Crohn's disease (CD) among first degree relatives (parents, siblings, or offspring) of Crohn's patients. The study will utilize the Western diet and the Mediterranean diet to explore the complex interplay between diet, microbiome, and inflammatory biomarkers to identify specific dietary components that may be beneficial in reducing the risk of developing CD. The study will enroll 30 participants from Mount Sinai Hospital in Toronto.
Detailed description
This study is a clinical trial that will occur at Mount Sinai Hospital and healthy first degree relatives of CD patients will be recruited. Participation will occur over 7 weeks with 1 week of consuming the subject's regular diet and 6 weeks of intervention. A total of 30 subjects are expected to be enrolled into this trial. As part of this trial, The study will attempt to modify dietary consumption between the Western Diet (WD) and the Mediterranean Diet (MD) to evaluate participants responses to specific food items key to the WD or MD by monitoring subject's GMRS and FCP. Subjects will be randomized into one of two groups (1:1), in which there will be crossover between the two diets. Stool samples will be collected 3 times a week, a daily questionnaire and a daily consumption diary will be completed through an app.
Group 1 will follow the WD for weeks 2 and 3, switch to the MD for weeks 4 and 5, and then back to the WD for weeks 6 and 7. Group 2 will follow the MD for weeks 2 and 3, switch to the WD for weeks 4 and 5, and then back to the MD for weeks 6 and 7.
Meal plans developed by the study Dietitian and recipes will be provided for all weeks of the intervention (weeks 2-7). These meal plans will be identical for subjects within the same group. Groceries required to prepare the meals as per the meal plan will be provided to subjects on a weekly basis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Western to Mediteranean to Western Diet | Other | Other: Mediteranean to Western to Mediteranean Diet, Other: Western to Mediteranean to Western DietWeeks 2 and 3 = WD Weeks 4 and 5 = MD Weeks 6 and 7 = WD |
| Mediteranean to Western to Mediteranean Diet | Other | Other: Mediteranean to Western to Mediteranean Diet, Other: Western to Mediteranean to Western DietWeeks 2 and 3 = MD Weeks 4 and 5 = WD Weeks 6 and 7 = MD |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy, asymptomatic first degree relative (child or sibling) of someone with Crohn's disease
- Have at least 1 bowel movement every other day
Key exclusion criteria (15 listed)
- Received antibiotic treatment within 3 months of recruitment
- Unintentional weight loss in the last 3 months more than 15% of baseline weight
- Have ever been diagnosed with any chronic or recurring gastro-intestinal disease or bowel disease
- Belly pain occurred more than once per week for longer than three months in the past year
- Diarrhea (>three times per day) has been occurring for more than three months in the last year
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 |
|---|---|---|
| Mediteranean to Western to Mediteranean Dietweek 2-3 : Switching between Mediterranean diet and Western diet week 4-5 : Switching between Western diet and Mediterranean diet week 6-7 : Switching between Mediterranean diet and Western diet | Other | Mediteranean to Western to Mediteranean Diet, Western to Mediteranean to Western Diet |
| Western to Mediteranean to Western Dietweek 2-3 : Switching between Western diet and Mediterranean diet week 4-5 : Switching between Mediterranean diet and Western diet week 6-7 : Switching between Western diet and Mediterranean diet | Other | Mediteranean to Western to Mediteranean Diet, Western to Mediteranean to Western Diet |
Primary outcome
Personalized model
Time frame: 7 weeks
Repeated measures of FCP and GMRS will be used to generate a personalized model identifying food items that provide are predicted to have the greatest effect in the GMRS and FCP levels for a given individual
5 secondary outcomes
Concentration of FCP levels over time during each intervention
Time frame: Duration of each diet (2 to 4 weeks)
Modulation of GMRS over time during each intervention
Time frame: Duration of each diet (2 to 4 weeks)
Measure of microbial taxa relative abundance over time during each intervention
Time frame: Duration of each diet (2 to 4 weeks)
Ability to maintain a balanced diet as measured by food intake records
Time frame: 6 weeks
Adherence to the interventions
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
Related trials for Diet, Healthy
Not yet recruiting
Testing a Smartphone App to Support a Mediterranean Diet and Strength Exercise
Treatment Adherence and Compliance, Resistance Exercise
Not yet recruiting
Effects of Ad Libitum Ultra-Processed Diet on Brain Dopamine in Humans
Healthy Volunteers
Recruiting
Nutrition Outcomes Using a Randomized Intervention Via Smartphone on Dietary Habits
Healthy Adult Participants, Mindful Eating Intervention
Not yet recruiting
Web-Based Sustainable Food Literacy Program for University Students
Food Literacy, Healthy Eating
Recruiting
Environmental Harm Menu Labels and Overall Dietary Quality
Food Choices
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.
Kenneth Croitoru principal investigator
MOUNT SINAI HOSPITAL
Questions about this trial
What is this clinical trial studying?
A study testing Mediteranean to Western to Mediteranean Diet and Western to Mediteranean to Western Diet in people with Diet, Healthy and High Risk, run by Mount Sinai Hospital, 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 2 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Williams Turpin, PhD (416-586-4800 ext. 2086, wturpin@lunenfeld.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personalized model (time frame: 7 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 19 Oct 2022.