Therapeutic Diet and Lifestyle for Multiple Sclerosis

Overseen By Mary Ehlinger, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Terry L. Wahls

Must not be taking: Insulin, Coumadin

Disqualifiers: Mental impairment, Claustrophobia, Schizophrenia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

44 Participants Needed

Trial Summary

What is the purpose of this trial?

A key question in efforts to reduce symptoms and improve quality of life for multiple sclerosis (MS) patients is whether a therapeutic lifestyle (diet, stress reduction and exercise) is inferior to disease-modifying drug treatments in terms of reducing multiple sclerosis related symptoms, improving function and quality of life, and reducing the number of acute inflammatory lesions and loss of brain volume. This study will prospectively assess the changes in quality of life and clinical outcomes in two cohorts of patients who are recently diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) to begin answering that question. The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor to the development of MS. Due to the COVID 19 Pandemic, the study was redesigned from an in-person study to a virtual visit only study prior to enrolling study subjects.

Research Team

Terry L Wahls, MD, MBA

Principal Investigator

University of Iowa

Eligibility Criteria

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

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Therapeutic Lifestyle Experimental Treatment 1 Intervention

Participants will be trained via videos from a three day in-person seminar that teaches the public about the use of a therapeutic diet and lifestyle to reduce multiple sclerosis related fatigue and improve quality of life.

Group II: Usual care Active Control 1 Intervention

Participants will receive usual care from their treating neurologist

Who Is Running the Clinical Trial?

Terry L. Wahls

Lead Sponsor

Trials

6

Recruited

400+