Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset
Primary Purpose
Diet, Healthy, High Risk
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mediteranean to Western to Mediteranean Diet
Western to Mediteranean to Western Diet
Sponsored by
About this trial
This is an interventional prevention trial for Diet, Healthy
Eligibility Criteria
Inclusion Criteria:
- Healthy, asymptomatic first degree relative (child or sibling) of someone with Crohn's disease
- Have at least 1 bowel movement every other day
Exclusion Criteria:
- 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
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Western to Mediteranean to Western Diet
Mediteranean to Western to Mediteranean Diet
Arm Description
Weeks 2 and 3 = WD Weeks 4 and 5 = MD Weeks 6 and 7 = WD
Weeks 2 and 3 = MD Weeks 4 and 5 = WD Weeks 6 and 7 = MD
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
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
Adherence to the interventions
Compliance to the diet will be monitored through an app throughout the study
Full Information
NCT ID
NCT05566587
First Posted
September 16, 2022
Last Updated
October 17, 2022
Sponsor
Mount Sinai Hospital, Canada
1. Study Identification
Unique Protocol Identification Number
NCT05566587
Brief Title
Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset
Official Title
Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mount Sinai Hospital, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet, Healthy, High Risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Western to Mediteranean to Western Diet
Arm Type
Other
Arm Description
Weeks 2 and 3 = WD Weeks 4 and 5 = MD Weeks 6 and 7 = WD
Arm Title
Mediteranean to Western to Mediteranean Diet
Arm Type
Other
Arm Description
Weeks 2 and 3 = MD Weeks 4 and 5 = WD Weeks 6 and 7 = MD
Intervention Type
Other
Intervention Name(s)
Mediteranean to Western to Mediteranean Diet
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Western to Mediteranean to Western Diet
Intervention Description
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
Primary Outcome Measure Information:
Title
Personalized model
Description
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
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Concentration of FCP levels over time during each intervention
Description
fecal calprotectin will be analyzed from all stool samples collected during the study to provide continual data on any changes in intestinal inflammation
Time Frame
Duration of each diet (2 to 4 weeks)
Title
Modulation of GMRS over time during each intervention
Description
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
Time Frame
Duration of each diet (2 to 4 weeks)
Title
Measure of microbial taxa relative abundance over time during each intervention
Description
Microbiome data will be collected from all stool samples collected during the study to provide continual data on any changes in microbial composition
Time Frame
Duration of each diet (2 to 4 weeks)
Title
Ability to maintain a balanced diet as measured by food intake records
Description
Through the submission of the daily food diaries an assessment on the ability to maintain the diet will be reviewed
Time Frame
6 weeks
Title
Adherence to the interventions
Description
Compliance to the diet will be monitored through an app throughout the study
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy, asymptomatic first degree relative (child or sibling) of someone with Crohn's disease
Have at least 1 bowel movement every other day
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Williams Turpin, PhD
Phone
416-586-4800
Ext
2086
Email
wturpin@lunenfeld.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Heather MacAulay, BSc, BSc
Phone
416-586-4800
Ext
8451
Email
hmacaulay@lunenfeld.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Croitoru
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset
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