Methionine-restricted diet and gut microbiota
Shaping Gut Microbiota Through a Dietary Intervention to Regulate Inflammatory Processes
We will test whether a methionine-restricted diet changes gut bacteria and inflammation in healthy adults aged 20–50.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 50 Years |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT07283328 on ClinicalTrials.gov |
What this trial studies
This is a randomized, crossover pilot with 40 healthy omnivorous adults who complete baseline, methionine-restricted (MR) diet, and supplementation/placebo periods over 10 weeks. Participants are randomized to receive either MR plus 1,500 mg daily methionine or MR plus placebo for two-week blocks, then cross over to the alternate supplement arm. Gut microbiota composition, blood methionine and metabolite levels, and immune/inflammatory markers are measured every two weeks. The design tests whether short-term dietary methionine restriction and controlled resupply alter microbiota and systemic inflammatory signals in humans.
Who should consider this trial
Good fit: Healthy omnivorous adults aged 20–50 who can follow a controlled diet, attend in-person visits, and understand French or English are ideal candidates.
Not a fit: People with active inflammatory or infectious disease, B12 deficiency, significant liver or kidney dysfunction, insulin-dependent diabetes, active cancer, pregnancy or lactation, eating disorders, severe food allergies, or other conditions preventing adherence are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could offer a simple dietary strategy to shift gut microbes and lower inflammation that might inform prevention or modification of immune-driven diseases.
How similar studies have performed: Animal studies and observational human data suggest methionine restriction can alter immunity and the microbiota, but randomized crossover intervention data in humans are limited and this design is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Montreal, Quebec
- Centre de recherche du Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Catherine Larochelle, MD, PhD
- Email: catherine.larochelle.med@ssss.gouv.qc.ca
- Phone: 514 890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.