Methionine Intake Microbiota
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methionine-restricted diet.
- Who it may be relevant to
- Registry conditions: Healthy. Basic parameters: 20 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Shaping Gut Microbiota Through a Dietary Intervention to Regulate Inflammatory Processes
Overview
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.
Interventions
- Behavioral 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 measures
- Gut microbiota [Time frame: At the end of week 2, 4, 6, 8, 10.]
Secondary outcome measures (2)
- 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.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Canada · 1 center
- Centre de recherche du Centre Hospitalier de l'Université de Montréal — Montreal
Identifiers
NCT: NCT07283328 · 23.111