Actively Recruiting

Phase Not Applicable
Age: 20Years - 50Years
All Genders
Healthy Volunteers
NCT07283328

Methionine Intake Microbiota

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-12-22

40

Participants Needed

1

Research Sites

79 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

M

Multiple Sclerosis Society of Canada

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Methionine Intake Microbiota

Who Can Participate

Age: 20Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adults
  • Between 20 and 50 years old
  • Following an omnivorous or western diet
  • Able to understand French or English
Not Eligible

You will not qualify if you...

  • Vitamin B12 deficiency
  • Glomerular filtration rate below 75 ml/h
  • Liver dysfunction
  • Pregnant or lactating
  • Having an active inflammatory or infectious disease
  • Insulin-dependent diabetes
  • Active cancer
  • Eating disorder
  • Body mass index below 18.5 kg/m2
  • Severe food allergies, intestinal problems, or active substance dependence preventing adherence to the diet

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Trial Site Locations

Total: 1 location

1

Centre de recherche du Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X 0A9

Actively Recruiting

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Research Team

C

Catherine Larochelle, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

OTHER

Number of Arms

2

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