Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05566587
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-09-16
Brief Title:
Designing a Personalized Diet to Reduce the Risk of Crohns Disease Onset
Sponsor:
Mount Sinai Hospital Canada
Organization:
Mount Sinai Hospital Canada
Study Overview
Official Title:
Designing a Personalized Diet to Reduce the Risk of Crohns Disease Onset
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Crohns disease CD among first degree relatives parents siblings or offspring of Crohns 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 subjects 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 subjects GMRS and FCP Subjects will be randomized into one of two groups 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None