Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study (Waves)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02914964 |
Recruitment Status :
Active, not recruiting
First Posted : September 26, 2016
Last Update Posted : May 18, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting | Behavioral: Swank Diet Behavioral: Wahls Elimination Diet | Not Applicable |
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 (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study |
Actual Study Start Date : | August 2016 |
Actual Primary Completion Date : | January 26, 2020 |
Estimated Study Completion Date : | January 26, 2025 |

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. |
- 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)
- 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)
- 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.
- 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.
- Change in participant walk speed [ Time Frame: 12-24 weeks ]6 Minute Walk Test
- Change in participant walk speed [ Time Frame: 12-36 weeks ]6 Minute Walk Test
- Change in gait (walk) [ Time Frame: 12-24 weeks ]25 foot Walk Test
- Change in gait (walk) [ Time Frame: 12-36 weeks ]25 foot Walk Test
- Change in fine motor function [ Time Frame: 12-24 weeks ]Pegboard test
- Change in fine motor function [ Time Frame: 12-36 weeks ]Pegboard test
- 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.
- 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.
- 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.
- 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.
- Change in steps per day [ Time Frame: 12-24 weeks ]Measured by accelerometer
- Change in steps per day [ Time Frame: 12-36 weeks ]Measured by accelerometer
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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.
- 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.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914964
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Iowa City, Iowa, United States, 52242 |
Principal Investigator: | Terry L Wahls, MD, MBA | University of Iowa | |
Principal Investigator: | Linda Snetselaar, PhD, RD, | University of Iowa |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Terry L. Wahls, Clinical Professor, University of Iowa |
ClinicalTrials.gov Identifier: | NCT02914964 |
Other Study ID Numbers: |
201604705 |
First Posted: | September 26, 2016 Key Record Dates |
Last Update Posted: | May 18, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Fatigue Quality of Life Diet |
Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Sclerosis Fatigue Pathologic Processes Demyelinating Autoimmune Diseases, CNS |
Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |