Methionine Intake Microbiota

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Enrolling

Conditions: Healthy

Treatments: Behavioral: Methionine-restricted diet

Study type: Interventional

Funder types: Other

Identifiers

NCT07283328

23.111

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Methionine supplementation

Experimental group

Description:

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.

Treatment:

Behavioral: Methionine-restricted diet

Placebo

Placebo Comparator group

Description:

Consumption of placebo pill trice daily for 2 weeks

Treatment:

Behavioral: Methionine-restricted diet