Designing a Personalized Diet to Reduce the Risk of Crohn's Disease Onset

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diet, Healthy; High Risk
• Intervention / Treatment: Other: Mediteranean to Western to Mediteranean Diet; Other: Western to Mediteranean to Western Diet

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Williams Turpin, PhD; Phone Number: 2086 416-586-4800; Email: wturpin@lunenfeld.ca
• Study Contact Backup: Name: Heather MacAulay, BSc, BSc; Phone Number: 8451 416-586-4800; Email: hmacaulay@lunenfeld.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Western to Mediteranean to Western Diet; Weeks 2 and 3 = WD Weeks 4 and 5 = MD Weeks 6 and 7 = WD	Other: Mediteranean to Western to Mediteranean Diet; 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; Other: Western to Mediteranean to Western Diet; 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
Other: Mediteranean to Western to Mediteranean Diet; Weeks 2 and 3 = MD Weeks 4 and 5 = WD Weeks 6 and 7 = MD	Other: Mediteranean to Western to Mediteranean Diet; 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; Other: Western to Mediteranean to Western Diet; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	6 weeks
Adherence to the interventions	Compliance to the diet will be monitored through an app throughout the study	6 weeks

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Investigators: Principal Investigator: Kenneth Croitoru, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: September 16, 2022
• First Submitted That Met QC Criteria: September 30, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: POP21-10037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No