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Therapeutic Diet and Lifestyle for Multiple Sclerosis

N/A

Waitlist Available

Led By Terry L Wahls, MD

Research Sponsored by Terry L. Wahls

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Must not have

Taking insulin or Coumadin® medication

History of oxalate kidney stones, schizophrenia, or active diagnosis of eating disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two groups of people with MS: those who only receive a diet and therapeutic lifestyle treatment, and those who receive usual care (which may include disease-modifying drugs). The study will look at changes in quality of life and clinical outcomes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes and lifestyle adjustments rather than medications, side effects may include typical reactions to diet change such as digestive discomfort. Stress reduction techniques and exercise are generally beneficial but could cause muscle soreness or emotional responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking insulin or Coumadin.

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I have had kidney stones, schizophrenia, or an eating disorder.

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It has been over a year since I was first diagnosed with RRMS or CIS.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MS 54 Quality of Life scale mental health score

MS 54 Quality of Life scale physical health score

Secondary study objectives

Anxiety Score -Hospital Anxiety and Depression Survey

Depression score -Hospital Anxiety and Depression Survey

Dietary intake

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Therapeutic LifestyleExperimental Treatment1 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 careActive Control1 Intervention

Participants will receive usual care from their treating neurologist

0 / 3Eligibility criteria met