Therapeutic Diet and Lifestyle for Multiple Sclerosis

ME
Overseen ByMary Ehlinger, BA
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

TL

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

My neurologist confirmed I have CIS or RRMS according to 2010 criteria within the last year.
Residence within the lower 48 states within the United States
Agreement by the treating neurologist that the patient may enroll in the study
See 1 more

Exclusion Criteria

You have a condition that makes it difficult to complete a brain MRI without feeling very uncomfortable.
I am currently taking insulin or Coumadin.
You have a significant problem with your memory or thinking abilities, as measured by a specific questionnaire.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a therapeutic lifestyle intervention including a low-lectin modified Paleolithic elimination diet, stress reduction, and exercise program, or usual care

12 months
Virtual visits only

Follow-up

Participants are monitored for changes in quality of life, CNS MRI results, and MS symptoms

12 months

Long-term monitoring

Continued monitoring of CNS MRI results and MS symptoms

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • Therapeutic diet and lifestyle
Trial Overview The study is testing whether a therapeutic lifestyle approach focusing on diet, stress reduction, and exercise can match or outperform standard drug treatments for reducing MS symptoms and improving life quality. It's a virtual study comparing these non-drug interventions against usual care in newly diagnosed CIS or RRMS patients.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Therapeutic LifestyleExperimental Treatment1 Intervention
Group II: Usual careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Terry L. Wahls

Lead Sponsor

Trials
6
Recruited
400+

Citations

From prevention to management: Exploring the impact of diet ...A follow-up study involving 20 MS patients confirmed similar reductions in fatigue and improvements in QoL (p < 0.0005) [36]. However, since ...
Efficacy of Diet on Quality of life in Multiple Sclerosis (EDQ-MS)In fact, up to 50% of people with MS report implementing dietary modifications to reduce their symptoms and improve the overall quality of life ...
Functional outcomes of diets in multiple sclerosis (FOOD ...Pilot trials indicate that both a low glycemic load (GL) diet and calorie restriction (CR) can be implemented successfully in people with multiple sclerosis ...
The Role of Diet and Interventions on Multiple SclerosisIn this review, we address the role of nutrition on MS pathogenesis as well as dietary interventions that show promising beneficial results.
Efficacy of Diet on Fatigue and Quality of Life in Multiple ...Preliminary trials suggest that dietary interventions may improve physical and mental QoL and reduce MS-related fatigue; however, these studies ...
Review article Efficacy and safety of the Mediterranean diet ...The study outcomes suggest that the Mediterranean diet can effectively treat patients with multiple sclerosis, yielding beneficial effects. The ...
Healthy Lifestyle Behaviors Linked to Better MS OutcomesEngaging with healthy lifestyle behaviors, including a healthy diet and physical activity, was associated with better outcomes among patients ...
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