Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study

Conditions
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Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
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* Behavioral: Swank Diet
* Behavioral: Wahls Elimination Diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Swank Diet<br>Individuals randomized to this arm will follow a low saturated fat diet starting at week 12. | Behavioral: Swank Diet<br>* 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.<br>|
| Experimental: Wahls Elimination Diet<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in participant perceived fatigue severity | 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 | 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 | 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 | 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 | 6 Minute Walk Test | 12-24 weeks | 
| Change in participant walk speed | 6 Minute Walk Test | 12-36 weeks | 
| Change in gait (walk) | 25 foot Walk Test | 12-24 weeks | 
| Change in gait (walk) | 25 foot Walk Test | 12-36 weeks | 
| Change in fine motor function | Pegboard test | 12-24 weeks | 
| Change in fine motor function | Pegboard test | 12-36 weeks | 
| Change in nutrient intake based on the recommended daily allowance (RDA) | 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) | 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 | 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 | 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 | Measured by accelerometer | 12-24 weeks | 
| Change in steps per day | Measured by accelerometer | 12-36 weeks | 
| Change in participant Quality of Life (QoL) - General Health | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fatigue, Quality of Life, Diet