Diets for Multiple Sclerosis

(Waves Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Terry L. Wahls

Must not be taking: Insulin, Coumadin

Disqualifiers: Cancer, Heart failure, Liver cirrhosis, others

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

Compensation: Varies

Number of Visits: Unknown

95 Participants Needed

Trial Summary

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.

Research Team

Linda Snetselaar, PhD, RD,

Principal Investigator

University of Iowa

Terry L Wahls, MD, MBA

Principal Investigator

University of Iowa

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Wahls Elimination Diet Experimental Treatment 1 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 Diet Experimental Treatment 1 Intervention

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

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+