NCT05566587

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mount Sinai Hospital, Canada · Academic / Other
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diet, Healthy
• High Risk

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-03-01
• Completion: 2024-03-01
• First posted: 2022-10-04
• Last updated: 2022-10-19