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

NCT05566587 | Unknown

• 1 other identifier: POP21-10037
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diet, Healthy; High Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Concentration of FCP levels over time during each intervention

  Duration of each diet (2 to 4 weeks)

• Modulation of GMRS over time during each intervention

  Duration of each diet (2 to 4 weeks)

• Measure of microbial taxa relative abundance over time during each intervention

  Duration of each diet (2 to 4 weeks)

• Ability to maintain a balanced diet as measured by food intake records

  6 weeks

• Adherence to the interventions

  6 weeks

Study Arms (2)

Western to Mediteranean to Western Diet

OTHER

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

Other: Mediteranean to Western to Mediteranean Diet; Other: Western to Mediteranean to Western Diet

Mediteranean to Western to Mediteranean Diet

OTHER

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

Other: Mediteranean to Western to Mediteranean Diet; Other: Western to Mediteranean to Western Diet

Interventions

Mediteranean to Western to Mediteranean Diet 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

Mediteranean to Western to Mediteranean Diet; Western to Mediteranean to Western Diet

Western to Mediteranean to Western Diet 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; Western to Mediteranean to Western Diet

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy, asymptomatic first degree relative (child or sibling) of someone with Crohn's disease
• Have at least 1 bowel movement every other day

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Officials

• Kenneth Croitoru

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Williams Turpin, PhD

CONTACT

416-586-4800; wturpin@lunenfeld.ca

Heather MacAulay, BSc, BSc

CONTACT

416-586-4800; hmacaulay@lunenfeld.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: October 4, 2022
• Study Start: October 1, 2022
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: October 19, 2022

Record last verified: 2022-10