95 Participants Needed

Diets for Multiple Sclerosis

(Waves Trial)

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?

The purpose of this study is to compare the effect of the Swank Diet (low saturated fat) and the Wahls Elimination Diet (modified paleo) on fatigue levels in individuals with relapsing-remitting multiple sclerosis who have documented fatigue. Participants will follow their usual diet for 12 weeks and then be randomly assigned to follow one of the two diets for 24 weeks.

Who Is on the Research Team?

LS

Linda Snetselaar, PhD, RD,

Principal Investigator

University of Iowa

TL

Terry L Wahls, MD, MBA

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Body Mass Index greater than or equal to 19
Ability to shop for and prepare or have someone in the family shop for and prepare home cooked meals according to study diet guidelines
Willingness to keep detailed food records
See 12 more

Exclusion Criteria

Moderate to severe mental impairment as measured by the Short Portable Mental Status questionnaire
Pregnant or planning to become pregnant in the next year
Participation in another research study that involves multiple sclerosis or other medications, diet, supplement, exercise or other treatments
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Diet

Participants follow their usual diet for 12 weeks

12 weeks
1 visit (in-person)

Dietary Intervention

Participants are randomly assigned to follow either the Swank Diet or the Wahls Elimination Diet for 24 weeks

24 weeks
3 visits (in-person)

Follow-up

Participants are monitored for changes in fatigue, motor function, cognitive function, and quality of life

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Swank Diet
  • Wahls Elimination Diet
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Wahls Elimination DietExperimental Treatment1 Intervention
Group II: Swank DietExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Terry L. Wahls

Lead Sponsor

Trials
6
Recruited
400+

National Multiple Sclerosis Society

Collaborator

Trials
100
Recruited
10,600+
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