← Back to Search

Diets for Multiple Sclerosis (Waves Trial)

N/A

Waitlist Available

Led By Linda Snetselaar, PhD, RD,

Research Sponsored by Terry L. Wahls

Eligibility Criteria Checklist

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

Must have

Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4

Between the ages of 18 and 70

Must not have

Taking insulin or Coumadin

Unwilling to have blood drawn

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-36 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two diets for their effect on fatigue in people with relapsing-remitting multiple sclerosis.

Who is the study for?

This trial is for adults aged 18-70 with relapsing-remitting multiple sclerosis and fatigue, willing to eat meat and more vegetables while cutting out comfort foods. Participants must not be pregnant or planning pregnancy, able to walk with minimal support, and capable of preparing meals according to diet guidelines.

What is being tested?

The study compares the Swank Diet (low in saturated fat) against the Wahls Elimination Diet (modified paleo) on reducing fatigue in multiple sclerosis patients. After a 12-week period of usual diet, participants are randomly assigned one of the diets for 24 weeks.

What are the potential side effects?

Potential side effects may include digestive changes due to new dietary habits. As these are diets focused on natural foods, severe side effects are unlikely but could involve nutrient deficiencies if not followed correctly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I often feel very tired.

Select...

I am between 18 and 70 years old.

Select...

I have had gastric bypass surgery and my doctor confirms I am weight stable and suitable for this study.

Select...

I can walk 25 feet by myself or with a cane.

Select...

My neurologist confirmed I have Relapsing-Remitting MS.

Exclusion Criteria

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

Select...

I am currently taking insulin or Coumadin.

Select...

I am not willing to have my blood drawn.

Select...

I have been treated for a cancer other than skin cancer in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-36 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-36 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-36 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Fatigue

Secondary study objectives

Change in cognitive function

Body Weight Changes

Change in gait (walk)

+8 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

Group I: Wahls Elimination DietExperimental Treatment1 Intervention

Individuals randomized to this arm will follow a modified paleolithic diet that eliminates all grains, dairy, eggs, legumes, and nightshade vegetables/spices starting at week 12.

Group II: Swank DietExperimental Treatment1 Intervention

Individuals randomized to this arm will follow a low saturated fat diet starting at week 12.

0 / 8Eligibility criteria met