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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-36 weeks

Awards & highlights

Waves Trial 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.Check my eligibility

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.See study design

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.

Waves Trial Eligibility Criteria

Inclusion Criteria

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

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I often feel very tired.

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I am between 18 and 70 years old.

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

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

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My neurologist confirmed I have Relapsing-Remitting MS.

Waves Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fatigue

Secondary outcome measures

Change in cognitive function

Body Weight Changes

Change in gait (walk)

+8 more

Waves 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 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Terry L. WahlsLead Sponsor

5 Previous Clinical Trials

295 Total Patients Enrolled

4 Trials studying Multiple Sclerosis

295 Patients Enrolled for Multiple Sclerosis

National Multiple Sclerosis SocietyOTHER

95 Previous Clinical Trials

9,383 Total Patients Enrolled

93 Trials studying Multiple Sclerosis

9,029 Patients Enrolled for Multiple Sclerosis

Linda Snetselaar, PhD, RD,Principal InvestigatorUniversity of Iowa

Media Library

Swank Diet Clinical Trial Eligibility Overview. Trial Name: NCT02914964 — N/A

Multiple Sclerosis Research Study Groups: Swank Diet, Wahls Elimination Diet

Multiple Sclerosis Clinical Trial 2023: Swank Diet Highlights & Side Effects. Trial Name: NCT02914964 — N/A

Swank Diet 2023 Treatment Timeline for Medical Study. Trial Name: NCT02914964 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still an opportunity for participants to enroll in this research?

"As reported on clinicaltrials.gov, this medical research is not recruiting at the moment; it was first published in August 2016 and last updated in May 2022. However, 748 other trials are presently enrolling patients."

Answered by AI

What are the overarching aims of this research project?

"This clinical trial, assessed over 12 to 36 weeks, hopes to gauge the Change in participant perceived fatigue severity. Secondary objectives include gauging changes in quality of life and mental health (Multiple sclerosis Quality of Life Questionnaire - Score 0-100), evaluating participants' depression levels (Hospital Anxiety and Depression Scale - 0-3) as well as total sleep time (measured by accelerometer)."

Answered by AI

Can I partake in this clinical exploration?

"A hundred individuals with Multiple sclerosis and recurrent relapses, between the ages of 18 to 70 years old can enroll in this research. To be accepted into the study, they must fulfil a few conditions: consume no more than one tablespoon of saturated fats or red meat per day; have a BMI higher or equal to 19; keep exact nutrition notes; permit their neurologist to certify MS diagnosis through an official document and demonstrate exhaustion as measured by Fatigue Severity Scale score 4+. Additionally, candidates ought not be pregnant now or plan pregnancy for at least one year ahead while also following dietary guidelines which prioritize vegetables over processed comfort food high on white"

Answered by AI

Is the age criteria for this research confined to individuals under 80 years old?

"This clinical trial requires that applicants meet the age requirement of 18-70. Separately, there are 53 trials for minors below 18 and 547 studies recruiting people above 65 years old."

Answered by AI

Recent research and studies

NutritionJournal

How Saturated Fats May Be a Causative Factor in Multiple Sclerosis and Other Diseases

Swank, R.L., and J.W. Goodwin. 2003. “How Saturated Fats May Be a Causative Factor in Multiple Sclerosis and Other Diseases”. Nutrition. Elsevier BV. doi:10.1016/s0899-9007(02)01099-7.

Archives of Neurology And PsychiatryJournal

Treatment of Multiple Sclerosis with Low-fat Diet

SWANK, ROY L.. 1953. “Treatment of Multiple Sclerosis with Low-fat Diet”. Archives of Neurology and Psychiatry. American Medical Association (AMA). doi:10.1001/archneurpsyc.1953.02320250097011.

NutritionJournal

How Saturated Fats May Be a Causative Factor in Multiple Sclerosis and Other Diseases

Swank, R.L., and J.W. Goodwin. 2003. “How Saturated Fats May Be a Causative Factor in Multiple Sclerosis and Other Diseases”. Nutrition. Elsevier BV. doi:10.1016/s0899-9007(02)01099-7.

Annals of Internal MedicineJournal