Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
- Conditions
- Multiple Sclerosis, Relapsing-RemittingMultiple Sclerosis
- Interventions
- Behavioral: Swank DietBehavioral: Wahls Elimination Diet
- Registration Number
- NCT02914964
- Lead Sponsor
- Terry L. Wahls
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Swank Diet Swank Diet Individuals randomized to this arm will follow a low saturated fat diet starting at week 12. Wahls Elimination Diet 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.
- Primary Outcome Measures
Name Time Method Change in the impact of fatigue on daily life 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 perceived fatigue severity 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)
- Secondary Outcome Measures
Name Time Method Change in gait (walk) 12-36 weeks 25 foot Walk Test
Change in participant walk speed 12-36 weeks 6 Minute Walk Test
Change in participant Quality of Life (QoL) - General Health 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 perceived depression 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.
Change in nutrient intake based on the recommended daily allowance (RDA) 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 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 perceived anxiety 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 steps per day 12-36 weeks Measured by accelerometer
Change in participant Quality of Life (QoL) - Mental Health 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 12-36 weeks Total sleep time is measured in hours and minutes and tracked by accelerometer worn by participants throughout the study
Change in fine motor function 12-36 weeks Pegboard test
Trial Locations
- Locations (1)
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States