Multiple Sclerosis Clinical Trial
Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
Summary
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.
Full 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.
Eligibility Criteria
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
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There is 1 Location for this study
Iowa City Iowa, 52242, United States
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