Methionine Intake Microbiota

NCT ID: NCT07283328

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-20

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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gut microbiota methionine diet intervention inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized interventional pilot study with cross-over intervention
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Methionine-restricted diet

Intervention Type BEHAVIORAL

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.

Placebo

Consumption of placebo pill trice daily for 2 weeks

Group Type PLACEBO_COMPARATOR

Methionine-restricted diet

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Multiple Sclerosis Society of Canada

OTHER

Sponsor Role collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Montreal, Quebec, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Catherine Larochelle, MD, PhD

Role: CONTACT

Phone: 514 890-8000

Email: [email protected]

Facility Contacts

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Catherine Larochelle, MD, PhD

Role: primary

Other Identifiers

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23.111

Identifier Type: -

Identifier Source: org_study_id