Shaping Gut Microbiota Through a Dietary Intervention to Regulate Inflammatory Processes

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Pro-inflammatory immune cells play a pivotal role in multiple sclerosis, and the gut microbiota is increasingly recognized as a key factor shaping the immune system. This study aims to determine the impact of a dietary intervention (methionine-restricted diet-MR) on gut microbiota and inflammation in humans. A randomized interventional pilot study with cross-over intervention is conducted in 40 healthy participants. For all participants, the first two weeks (week 1+week 2) consist of baseline assessment on their usual diet, and week 3+week 4 consist of MR diet only. For group A, the week 5+week 6 are MR+1,500 mg daily supplementation of methionine and for group B are MR+placebo, with a cross-over for week 7+week 8. Usual diet is resumed for all participants during week 9+week 10. Gut microbiota, blood levels of methionine and its metabolites, as well as immune and inflammatory markers will be evaluated every 2 weeks. It is hypothesized that MR could be used in humans to prevent and alleviate the course of multiple sclerosis by shaping the gut microbiota towards an anti-inflammatory profile, and that the gut microbiota is a biomarker associated with successful dietary interventions targeting inflammation in multiple sclerosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 50
Healthy Volunteers: t
View:

• Healthy adults

• 20-50 years old

• On omnivorous/western diet

• Understanding French or English

Locations
Other Locations
Canada
Centre de recherche du Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Contact Information
Primary
Catherine Larochelle, MD, PhD
catherine.larochelle.med@ssss.gouv.qc.ca
514 890-8000
Time Frame
Start Date: 2024-08-20
Estimated Completion Date: 2026-03
Participants
Target number of participants: 40
Treatments
Experimental: Methionine supplementation
Methionine supplementation will be achieved using commercially available methionine supplement (content methionine 500 mg, trice daily) with a monography from Health Canada (NPN 80017685) and compared to placebo pills.
Placebo_comparator: Placebo
Consumption of placebo pill trice daily for 2 weeks
Related Therapeutic Areas
Sponsors
Leads: Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: Multiple Sclerosis Society of Canada

This content was sourced from clinicaltrials.gov

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