Therapeutic Diet and Lifestyle for Multiple Sclerosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a therapeutic lifestyle, including diet, stress reduction, and exercise, can match the effectiveness of traditional drug treatments for people with multiple sclerosis (MS), specifically those with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS). Participants will be divided into two groups: one receiving standard care from their neurologist and the other following the therapeutic lifestyle program. The study will examine changes in symptoms, function, and quality of life. Individuals diagnosed with CIS or RRMS within the last year and residing in the lower 48 states of the U.S. may be eligible.
As an unphased trial, this study provides a unique opportunity to explore alternative treatments that could enhance quality of life.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications, but it does exclude those taking insulin or Coumadin®. It's best to discuss your specific medications with the study team.
What prior data suggests that this therapeutic lifestyle is safe for multiple sclerosis patients?
Research has shown that lifestyle changes, such as eating a healthy diet and exercising, can significantly help manage multiple sclerosis (MS) symptoms. Studies have found that these changes can reduce inflammation and improve the quality of life for people with MS. For instance, one study found that the Mediterranean diet, which includes many fruits, vegetables, and healthy fats, is not only safe but also effective in treating MS.
Another study revealed that half of the people with MS change their diets to help manage their symptoms. These lifestyle changes are usually well-tolerated, meaning most people do not experience negative side effects. Instead, they often feel more energetic and generally better.
Overall, evidence suggests that focusing on a healthy lifestyle can be a safe and helpful way to manage MS symptoms.12345Why are researchers excited about this trial?
Researchers are excited about the therapeutic diet and lifestyle approach for multiple sclerosis (MS) because it offers a non-pharmacological alternative to traditional treatments like disease-modifying therapies (DMTs), which often involve injectable or oral medications. Unlike these standard options, which primarily target the immune system to slow disease progression, the therapeutic lifestyle focuses on reducing MS-related fatigue and enhancing quality of life through diet and lifestyle changes. This method emphasizes patient empowerment by equipping individuals with practical strategies to manage their condition actively. By exploring how lifestyle adjustments can impact MS, researchers hope to uncover new avenues for improving patient well-being without relying solely on medication.
What evidence suggests that a therapeutic diet and lifestyle might be an effective treatment for multiple sclerosis?
Research has shown that changes in diet and lifestyle can reduce tiredness and improve the quality of life for people with multiple sclerosis (MS). In this trial, participants in the Therapeutic Lifestyle arm will receive training through seminar videos on using a therapeutic diet and lifestyle to reduce MS-related fatigue and enhance quality of life. One study found that MS patients felt less tired and experienced a better quality of life after changing their diet. Up to 50% of people with MS have reported that dietary changes help manage their symptoms. Early studies also suggest that diets low in sugar and calories can benefit people with MS. These findings highlight the potential benefits of focusing on diet and lifestyle to ease MS symptoms.12567
Who Is on the Research Team?
Terry L Wahls, MD, MBA
Principal Investigator
University of Iowa
Are You a Good Fit for This Trial?
This trial is for individuals in the lower 48 states of the US who have been recently diagnosed with Clinically Isolated Syndrome (CIS) or Relapsing-Remitting Multiple Sclerosis (RRMS). They must be willing to share clinical notes and get approval from their neurologist. People with moderate/severe mental impairment, contraindications to MRI, certain medication use, or specific medical conditions are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a therapeutic lifestyle intervention including a low-lectin modified Paleolithic elimination diet, stress reduction, and exercise program, or usual care
Follow-up
Participants are monitored for changes in quality of life, CNS MRI results, and MS symptoms
Long-term monitoring
Continued monitoring of CNS MRI results and MS symptoms
What Are the Treatments Tested in This Trial?
Interventions
- Therapeutic diet and lifestyle
Find a Clinic Near You
Who Is Running the Clinical Trial?
Terry L. Wahls
Lead Sponsor