Methionine Intake Microbiota

NCT07283328 | Recruiting

• 1 other identifier: 23.111
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

gut microbiota; methionine; diet intervention; inflammation

Outcome Measures

Primary Outcomes (1)

• Gut microbiota

  Lipocalin-2 will be measured in stools to assess for inflammation in the gut. Stool samples from a given participant (all timepoints) will be processed simultaneously for DNA extraction and sequencing. Amplification of hyper-variable regions V1-V3 of 16S with primers, 16S libraries preparation and sequencing (Génome Québec) will be performed. Microbiota diversity will be measured with Shannon and α-diversity indexes. To represent microbial communities' similarity/difference between groups, a principal coordinates analysis (PCoA) will be used. Data will be interpreted by using high dimensional class comparisons via linear discriminant analysis of effect size (LEfSe) and volcano plots to identify potential relationships between specific bacteria and immunological/metabolomics results and clinical data.

  At the end of week 2, 4, 6, 8, 10.

Secondary Outcomes (2)

• Immune and inflammatory profile

  At the end of week 2 ,4, 6, 8, 10.

• Methionine level

  At the end of week 2, 4, 6, 8, 10.

Study Arms (2)

Methionine supplementation

EXPERIMENTAL

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.

Behavioral: Methionine-restricted diet

Placebo

PLACEBO COMPARATOR

Consumption of placebo pill trice daily for 2 weeks

Behavioral: Methionine-restricted diet

Interventions

Methionine-restricted diet 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.

Methionine supplementation; Placebo

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Multiple Sclerosis Society of Canada: collaborator

Study Sites (1)

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

Montreal, Quebec, H2X 0A9, Canada

RECRUITING

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Catherine Larochelle, MD, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized interventional pilot study with cross-over intervention

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: August 20, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)