HealthyNCT07283328
Methionine Intake Microbiota
A study testing Methionine-restricted diet in people with Healthy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Methionine-restricted diet
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 20 Aug 2024to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults
- 20-50 years old
- On omnivorous/western diet
- Understanding French or English
Who cannot join
- B12 deficiency
- Glomerular filtration rate <75 ml/h
- Liver dysfunction
- Pregnant or lactating
- Active inflammatory or infectious disease
- Insulino-dependent diabetes
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Catherine Larochelle, MD, PhD contact
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche du Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 0A9
Catherine Larochelle, MD, PhD, 514 890-8000 ext. 15370, catherine.larochelle.med@ssss.gouv.qc.ca
Catherine Larochelle, MD, PhD
About this study
Official title: Shaping Gut Microbiota Through a Dietary Intervention to Regulate Inflammatory Processes
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
- Being tested
- Methionine-restricted diet
- Keywords
- gut microbiota, methionine, diet intervention, inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methionine-restricted dietBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Methionine-restricted diet |
| Placebo | Placebo comparator | Consumption of placebo pill trice daily for 2 weeks Receives: Behavioral: Methionine-restricted diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of week 2, 4, 6, 8, 10.
Secondary outcomes (2)
Immune and inflammatory profile
Established FACS panels will be used to characterize the complete immune profile including markers for B cells, T cells, myeloid cells, and CAMs implicated in gut and CNS homing. Validated multiplex immunoassays will be used on serum and supernatants to assess immune/inflammatory markers and metabolic markers (leptin, adiponectin, FGF21) in serum. In addition, sCD14, intestinal-type fatty acid-binding protein, and soluble suppression of tumorigenicity 2, which all correlated with gut damage in humans, will be measured.
Measured: At the end of week 2 ,4, 6, 8, 10.
Methionine level
Levels of methionine and its metabolites (SAM and SAH) will be measured by LC-MS (serum and PBMCs).
Measured: At the end of week 2, 4, 6, 8, 10.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start20 Aug 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized interventional pilot study with cross-over intervention
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07283328
- Sponsor's protocol ID
- 23.111
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shaping Gut Microbiota Through a Dietary Intervention to Regulate Inflammatory Processes
- ClinicalTrials.gov ID
- NCT07283328
- Acronym / sponsor ID
- 23.111
- Conditions
- Healthy
- Keywords
- gut microbiota, methionine, diet intervention, inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Multiple Sclerosis Society of Canada
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized interventional pilot study with cross-over intervention
| Arm | Type | Receives |
|---|---|---|
| Methionine supplementation | Experimental | Behavioral: Methionine-restricted dietMethionine 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 | Placebo comparator | Behavioral: Methionine-restricted dietConsumption of placebo pill trice daily for 2 weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy adults
- 20-50 years old
- On omnivorous/western diet
- Understanding French or English
Key exclusion criteria (10 listed)
- B12 deficiency
- Glomerular filtration rate <75 ml/h
- Liver dysfunction
- Pregnant or lactating
- Active inflammatory or infectious disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methionine-restricted dietMethionine-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. | Behavioural | Methionine supplementation, Placebo |
Primary outcome
Gut microbiota
Time frame: At the end of week 2, 4, 6, 8, 10.
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.
2 secondary outcomes
Immune and inflammatory profile
Time frame: At the end of week 2 ,4, 6, 8, 10.
Methionine level
Time frame: At the end of week 2, 4, 6, 8, 10.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Larochelle, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methionine-restricted diet in people with Healthy, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Catherine Larochelle, MD, PhD (514 890-8000 ext. 15370, catherine.larochelle.med@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut microbiota (time frame: At the end of week 2, 4, 6, 8, 10.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.