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: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different diets might impact fatigue in people with relapsing-remitting multiple sclerosis. Participants will first follow their usual diet, then try either the Swank Diet, low in saturated fats, or the Wahls Elimination Diet, a modified paleo diet. This trial suits individuals with multiple sclerosis who experience fatigue and are open to significantly changing their eating habits. Participants must be able to walk short distances and prepare meals. As an unphased trial, this study provides a unique opportunity for participants to explore dietary changes that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking insulin or Coumadin.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the Swank and Wahls Elimination diets are generally safe for people with multiple sclerosis. One study found that these diets can reduce tiredness and improve quality of life for up to 24 weeks, indicating they are well-tolerated by most individuals.

The Swank Diet is low in saturated fats, and reviews suggest it can help with tiredness and overall well-being in people with multiple sclerosis. No strong evidence indicates major safety concerns.

The Wahls Elimination Diet is a modified paleo diet that excludes grains, dairy, eggs, legumes, and some vegetables. While it can enhance mental quality of life, caution is advised as eliminating these foods might lead to nutrient deficiencies.

Overall, both diets appear safe for most individuals, but consulting a healthcare provider before making significant dietary changes is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these dietary treatments for multiple sclerosis (MS) because they offer a unique, non-pharmaceutical approach that could complement or even reduce the need for standard medications like disease-modifying therapies. The Swank Diet is distinctive for its focus on drastically reducing saturated fat intake, which may help reduce inflammation and slow disease progression. The Wahls Elimination Diet stands out by eliminating grains, dairy, eggs, legumes, and nightshade vegetables, aiming to optimize nutrient intake and reduce autoimmunity triggers. These diets are intriguing because they empower individuals with MS to potentially manage symptoms through lifestyle changes rather than solely relying on medication.

What evidence suggests that this trial's diets could be effective for reducing fatigue in multiple sclerosis?

In this trial, participants will be randomized to follow either the Swank Diet or the Wahls Elimination Diet. Research has shown that both diets can reduce tiredness and improve the quality of life for people with multiple sclerosis (MS). One study found that following these diets for up to 24 weeks led to these positive effects. Participants in one arm of this trial will follow the Swank Diet, which is low in saturated fat and may slow the progression of MS. Meanwhile, participants in another arm will follow the Wahls Elimination Diet, a modified paleo diet that improves tiredness and quality of life by focusing on nutrient-rich foods. To achieve these benefits, adherence to the assigned diet is crucial. ^{1 4 6 7 8}

Who Is on the Research Team?

Linda Snetselaar, PhD, RD,

Principal Investigator

University of Iowa

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

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

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?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8326636/

Impact of the Swank and Wahls elimination dietary ... These findings demonstrate that adoption of the Swank or Wahls diets is associated with reduced fatigue and improved QoL for up to 24 weeks. High diet adherence ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0899900702008511

Review of MS patient survival on a Swank low saturated fat ... This article describes the most recent findings of the study and presents the striking result that approximately 20% of these MS patients on the lowest fat diet ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10243296/

Effectiveness of various diet patterns among patients with ... An appropriate and balanced diet can be extremely helpful in improving the condition and well-being of patients with MS, and effectively support drug therapy.

4. drmcdougall.com drmcdougall.com/education/information-all/results-of-the-diet-multiple-sclerosis-study/

Results of the Diet & Multiple Sclerosis Study Dr. Swank published dozens of studies in major medical journals showing that a low-fat diet would essentially stop the progression of MS.

5. verywellhealth.com verywellhealth.com/swank-diet-for-multiple-sclerosis-2440476

The Swank Diet for Multiple Sclerosis The Swank diet was developed by a neurologist to help manage multiple sclerosis. Learn about the theories behind the diet and how to follow ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12086631/

From prevention to management: Exploring the impact of diet ... Overall, the Swank diet shows potential for reducing fatigue, enhancing cognitive function, and improving QoL in MS. However, limitations such ...

7. nationalmssociety.org nationalmssociety.org/news-and-magazine/news/two-diets-reduce-fatigue-improve-qol

Study Shows Benefits of Diets in RRMS A clinical trial studying the Swank and Wahls elimination diets show reduced fatigue and improvements in quality of life for RRMS.

8. msard-journal.com msard-journal.com/article/S2211-0348(16)30100-6/pdf

Low-fat, plant-based diet in multiple sclerosis The outcomes of interest included 1) diet adherence, safety, and tolerability, 2) changes in brain MRI, MS clinical activity, fatigue and quality of life (QOL) ...