40 Participants Needed

Methionine-Restricted Diet for None

CL
Overseen ByCatherine Larochelle, MD, PhD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a special diet that limits methionine, a protein building block found in many foods, affects gut bacteria and inflammation. Researchers believe this could help prevent or manage multiple sclerosis, a condition where the immune system mistakenly attacks the nervous system. Initially, participants will follow their usual diet, then switch to the methionine-restricted diet, with some receiving methionine supplements or a placebo. The study seeks healthy adults who eat a typical Western diet, are not pregnant, and do not have certain medical issues like diabetes or severe food allergies. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new dietary strategies for managing multiple sclerosis.

What prior data suggests that this dietary intervention is safe?

Research has shown that a methionine-restricted diet (MRD) is generally safe for people, with studies finding no major side effects. For example, one study found no serious problems linked to the diet. Although it showed changes in methionine levels in the blood, these did not lead to any health issues.

Additionally, MRD has been associated with health benefits, such as improved muscle and metabolic health. This suggests that the diet not only appears safe but might also enhance overall well-being. While the current study focuses on healthy participants, these findings can reassure participants about the diet's safety.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effects of a methionine-restricted diet, a novel dietary approach, rather than the typical drug-based treatments. Methionine is an amino acid found in many foods, and restricting its intake might offer a unique way to address certain health issues by altering metabolic pathways. This line of investigation could uncover new insights into how diet influences health, potentially leading to innovative nutritional strategies that differ from traditional medication-based treatments.

What evidence suggests that a methionine-restricted diet could be effective for multiple sclerosis?

Research has shown that a diet low in methionine, an amino acid, has promising effects in animals. In studies with mice, this diet improved metabolism and quickly addressed obesity-related issues. It also enhanced muscle and nerve function and improved overall health in older animals. Although limited research exists on humans, a methionine-restricted diet is believed to positively affect gut bacteria and reduce inflammation, potentially aiding conditions like multiple sclerosis. This trial will compare methionine supplementation with a placebo. The methionine-restricted diet might alter gut bacteria to reduce inflammation, benefiting immune health.34678

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in how diet affects gut bacteria and inflammation. Participants will follow a special low-methionine diet and take either methionine supplements or a placebo. Specific eligibility details are not provided, but typically participants must be adults without serious health issues.

Inclusion Criteria

On omnivorous/western diet
I understand French or English.
I am between 20 and 50 years old and healthy.

Exclusion Criteria

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
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Baseline Assessment

Participants are assessed on their usual diet

2 weeks
1 visit (in-person)

Methionine-Restricted Diet

Participants follow a methionine-restricted diet

2 weeks
1 visit (in-person)

Intervention Phase 1

Group A receives MR+1,500 mg methionine, Group B receives MR+placebo

2 weeks
1 visit (in-person)

Intervention Phase 2 (Cross-over)

Group A receives MR+placebo, Group B receives MR+1,500 mg methionine

2 weeks
1 visit (in-person)

Return to Usual Diet

Participants resume their usual diet

2 weeks
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Methionine-restricted diet

Trial Overview

The study tests the effects of a methionine-restricted diet on gut microbiota and inflammation, which could influence immune system diseases like multiple sclerosis. It's a pilot study with 40 people who switch between their normal diet, the restricted diet, and added supplements over ten weeks.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Methionine supplementationExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Multiple Sclerosis Society of Canada

Collaborator

Trials
17
Recruited
990+

Citations

The Impact of Dietary Methionine Restriction on Biomarkers of ...

The original studies of dietary MR in rats showed that in addition to increasing life span, the diet produced a lifelong reduction in body weight and ...

Dietary methionine restriction started late in life promotes ...

MetR significantly improved neuromuscular function, metabolic health, lung function, and frailty. In addition, we confirmed improved ...

Methionine restriction and mimetics to ameliorate human ...

Studies in murine diet-induced obesity demonstrate that MetR is most effective within a relatively narrow range of dietary methionine content.

Short‐term dietary methionine restriction with high fat diet ...

In mice with diet-induced obesity, methionine restriction with a high fat diet dramatically reverses metabolic dysfunction within 10 days.

Methionine restriction plus overload improves skeletal ...

MR in combination with resistance training may improve skeletal muscle and metabolic health in old age even in the face of obesity.

A Phase I Trial of a Methionine Restricted Diet with ...

Preclinical evidence suggests a methionine restricted diet (MRD) sensitizes cancer to radiation therapy (RT), without significant adverse effects. However, this ...

Safety and feasibility of the addition of a radiosensitizing ...

There was no grade 3 or higher adverse events attributable to the MRD. Methionine plasma levels varied over the course of treatment, and while ...

Acute dietary methionine restriction triggers cell cycle ...

Short-term methionine restriction during gestation leads to reversible microcephaly. Neural progenitors enter into S/G2 quiescence upon methionine restriction.