Recruiting

Methionine-Restricted Diet

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT07283328

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Accepted

Interventions

Methionine-restricted diet

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT07283328

Start date

Aug 20, 2024

Status verified date

Dec, 2025

Completion date

Mar, 2026

Anticipated

Primary completion date

Mar, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy adults
  • 20-50 years old
  • On omnivorous/western diet
  • Understanding French or English

Exclusion Criteria:

  • B12 deficiency
  • Glomerular filtration rate <75 ml/h
  • Liver dysfunction
  • Pregnant or lactating
  • Active inflammatory or infectious disease
  • Insulino-dependent diabetes
  • Active cancer
  • Eating disorder
  • BMI < 18.5 kg/m2
  • Severe food allergies or intestinal problems or active substance dependence that would prevent adherence to the experimental diet

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

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

Interventions

Methionine-restricted diet

Methionine-restricted diet (plant-based diet) is a feasible and palatable way to achieve 50% reduction in methionine intake. Reduction to around 800 mg/day methionine will be achieved using participants' selection from low-methionine plant-based and ready to eat meals for 100% of their meals, for 6 weeks. Participants will be provided with education and a list of low methionine content food (green) and high methionine (red) for eating out, snacks and homemade meals.

Primary outcome measure

  • Gut microbiota [ Time Frame: At the end of week 2, 4, 6, 8, 10. ]

Central Contacts and Locations

Central contacts

Catherine Larochelle, MD, PhD

514 890-8000catherine.larochelle.med@ssss.gouv.qc.ca

Locations

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

Recruiting

Montreal, Quebec, Canada, H2X 0A9

Contacts

Catherine Larochelle, MD, PhD

514 890-8000catherine.larochelle.med@ssss.gouv.qc.ca

Principal Investigator:

Catherine Larochelle, MD, PhD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • gut microbiota
  • methionine
  • diet intervention
  • inflammation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2025-12-22.