Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study (Waves)

July 11, 2023 updated by: Terry L. Wahls
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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. Individuals will continue with their current treatments in addition to following the study diet.

The study requires four visits to the University of Iowa Hospitals and Clinics in Iowa City, Iowa. Visits will be 12 weeks apart. Study activities include fasting blood draws, weighed food records, motor and cognitive testing, physical activity assessment, questionnaires, and daily diet checklists while following the study diet. Some reimbursement available.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Willing to allow your neurologist to sign a letter confirming multiple sclerosis diagnosis and criteria used in diagnosis
  • Relapsing-Remitting Multiple Sclerosis as documented by the McDonald Criteria confirmed by their treating neurologist
  • Fatigue as documented by a Fatigue Severity Scale score of greater than or equal to 4
  • Between the ages of 18 and 70
  • 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
  • Willing to eat a diet that includes more vegetables and excludes many comfort foods such as those made with white flour,
  • Willing to eat a diet that eliminates red meat (beef, pork, lamb, veal) and saturated fats (butter, coconut oil, margarine, hydrogenated oils found in processed foods) to 1 tablespoon per day
  • Must not be pregnant or planning to become pregnant in the next year
  • Willing to eat meat (eg, chicken, turkey, fish)
  • Willingness to follow either the Wahls Elimination diet or the Swank diet
  • Individuals who have had gastric bypass surgery have obtained a signed statement from their physician indicating they are weight stable and a suitable candidate for this study
  • Normal or mild cognitive impairment as measured by the Short Portable Mental Status Questionnaire
  • Willing to have blood drawn
  • Be able to walk 25 feet without support, or with only unilateral support (i.e. cane in one hand)

Exclusion Criteria:

  • Taking insulin or Coumadin
  • Relapse within past 12 weeks
  • Treatment for a cancer (other than skin cancer) currently or in the prior 12 months
  • Diagnosis of heart failure, liver cirrhosis, angina, history of kidney stones, psychiatric disease likely to make adherence to the study interventions more difficult including eating disorders, but excluding depression and anxiety
  • Body Mass Index less than 19
  • Moderate to severe mental impairment as measured by the Short Portable Mental Status questionnaire
  • Inability to shop for and prepare home cooked meals by the subject or a companion
  • Unwillingness to eat meat
  • Participation in another research study that involves multiple sclerosis or other medications, diet, supplement, exercise or other treatments
  • Inability to keep food records with sufficient detail to asses dietary intake or complete study questionnaires
  • Unwilling to have blood drawn
  • Pregnant or planning to become pregnant in the next year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Swank Diet
Individuals randomized to this arm will follow a low saturated fat diet starting at week 12.
Behavioral: Swank Diet
A Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling to study participants to assist them in following the Swank Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention.
Experimental: Wahls Elimination Diet
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.
Behavioral: Wahls Elimination Diet
A Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling using to study participants to assist them in following the Wahls Elimination Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participant perceived fatigue severity
Time Frame: 12-24 weeks
Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)
12-24 weeks
Change in participant perceived fatigue severity
Time Frame: 12-36 weeks
Participant questionnaire asking about fatigue: Fatigue Severity Scale score - a 9-questions scale ranging from 1 (complete disagreement with the question) to 7 (complete agreement with the questions)
12-36 weeks
Change in the impact of fatigue on daily life
Time Frame: 12-24 weeks
Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.
12-24 weeks
Change in the impact of fatigue on daily life
Time Frame: 12-36 weeks
Modified Fatigue Impact Scale score: Participant questionnaire asking about impact of fatigue impact daily life: Modified Fatigue Impact Scale score. This instrument provides an assessment of the effects of fatigue in terms of physical, cognitive, and psychosocial functioning. The MFIS consists of 21 items. Scoring is based upon a sum of the responses. Total score ranges from 0 to 84.
12-36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in participant walk speed
Time Frame: 12-24 weeks
6 Minute Walk Test
12-24 weeks
Change in participant walk speed
Time Frame: 12-36 weeks
6 Minute Walk Test
12-36 weeks
Change in gait (walk)
Time Frame: 12-24 weeks
25 foot Walk Test
12-24 weeks
Change in gait (walk)
Time Frame: 12-36 weeks
25 foot Walk Test
12-36 weeks
Change in fine motor function
Time Frame: 12-24 weeks
Pegboard test
12-24 weeks
Change in fine motor function
Time Frame: 12-36 weeks
Pegboard test
12-36 weeks
Change in nutrient intake based on the recommended daily allowance (RDA)
Time Frame: 12-24 weeks
Nutrient intake calculated from 3-day weighed food records and Food Frequency Questionnaire and Participant blood measurements of insulin, glucose, hemoglobin A1C, Vitamin K, homocysteine, lipids, fatty acid profile and vitamin D.
12-24 weeks
Change in nutrient intake based on the recommended daily allowance (RDA)
Time Frame: 12-36 weeks
Nutrient intake calculated from 3-day weighed food records and Food Frequency Questionnaire and Participant blood measurements of insulin, glucose, hemoglobin A1C, Vitamin K, homocysteine, lipids, fatty acid profile and vitamin D.
12-36 weeks
Change in cognitive function
Time Frame: 12-24 weeks
Symbol Digit Modalities Test - oral. An oral test of sequencing symbols. •Participant substitutes a number for meaningless geometric shapes based on a key that assigns a specific number to each shape. Scoring is based on the number of correct substitutions.
12-24 weeks
Change in cognitive function
Time Frame: 12-36 weeks
Symbol Digit Modalities Test - oral. An oral test of sequencing symbols. •Participant substitutes a number for meaningless geometric shapes based on a key that assigns a specific number to each shape. Scoring is based on the number of correct substitutions.
12-36 weeks
Change in steps per day
Time Frame: 12-24 weeks
Measured by accelerometer
12-24 weeks
Change in steps per day
Time Frame: 12-36 weeks
Measured by accelerometer
12-36 weeks
Change in participant Quality of Life (QoL) - General Health
Time Frame: 12-24 weeks
Multiple Sclerosis 54 Quality of Life Questionnaire. A series of questions about quality of life and social functioning. Score 0 to 100.
12-24 weeks
Change in participant Quality of Life (QoL) - General Health
Time Frame: 12-36 weeks
Multiple Sclerosis Quality of Life Questionnaire. A series of questions about quality of life and social functioning. Score 0 to 100.
12-36 weeks
Change in participant Quality of Life (QoL) - Mental Health
Time Frame: 12-24 weeks
Multiple Sclerosis Quality of Life Questionnaire A series of questions about quality of life and social functioning. Score 0 to 100.
12-24 weeks
Change in participant Quality of Life (QoL) - Mental Health
Time Frame: 12-36 weeks
Multiple Sclerosis Quality of Life Questionnaire A series of questions about quality of life and social functioning. Score 0 to 100.
12-36 weeks
Change in total sleep time
Time Frame: 12-24 weeks
Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study
12-24 weeks
Change in total sleep time
Time Frame: 12-36 weeks
Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study
12-36 weeks
Change in perceived anxiety
Time Frame: 12-24 weeks
Perceived anxiety is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.
12-24 weeks
Change in perceived anxiety
Time Frame: 12-36 weeks
Perceived anxiety is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.
12-36 weeks
Change in perceived depression
Time Frame: 12-24 weeks
Perceived depression is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.
12-24 weeks
Change in perceived depression
Time Frame: 12-36 weeks
Perceived depression is measured by the Hospital Anxiety and Depression Scale (HADS), a 14 question scale ranging from 0-3 with zero being being low or no occurrence and 3 being high occurrence.
12-36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terry L. Wahls

Collaborators

National Multiple Sclerosis Society

Investigators

  • Principal Investigator: Terry L Wahls, MD, MBA, University of Iowa
  • Principal Investigator: Linda Snetselaar, PhD, RD,, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

January 26, 2020

Study Completion (Estimated)

January 26, 2025

Study Registration Dates

First Submitted

September 13, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimated)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201604705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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