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

NCT ID: NCT05566587

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-31
• Study Completion Date: 2024-03-31

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.

Conditions

Diet, Healthy; High Risk

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Western to Mediteranean to Western Diet

Weeks 2 and 3 = WD Weeks 4 and 5 = MD Weeks 6 and 7 = WD

Group Type: OTHER

Mediteranean to Western to Mediteranean Diet

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Mediteranean to Western to Mediteranean Diet

Weeks 2 and 3 = MD Weeks 4 and 5 = WD Weeks 6 and 7 = MD

Group Type: OTHER

Mediteranean to Western to Mediteranean Diet

Intervention Type: OTHER

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

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Ken Croitoru

Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Croitoru

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Central Contacts

Williams Turpin, PhD

Role: CONTACT

wturpin@lunenfeld.ca

416-586-4800 ext. 2086

Heather MacAulay, BSc, BSc

Role: CONTACT

hmacaulay@lunenfeld.ca

416-586-4800 ext. 8451

Other Identifiers

POP21-10037

Identifier Type: -

Identifier Source: org_study_id