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

Diet, Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05566587
• Other study ID #: POP21-10037
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2022
• Est. completion date: March 2024

Study information

• Verified date: October 2022
• Source: Mount Sinai Hospital, Canada
• Contact: Williams Turpin, PhD
• Phone: 416-586-4800
• Email: wturpin[@]lunenfeld.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Diet, Healthy
• High Risk

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	Adherence to the interventions	Compliance to the diet will be monitored through an app throughout the study	6 weeks