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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Enrollment
95
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.
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.
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 12-36 weeks
Change in participant walk speed
6 Minute Walk Test
Time frame: 12-24 weeks
Change in participant walk speed
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6 Minute Walk Test
Time frame: 12-36 weeks
Change in gait (walk)
25 foot Walk Test
Time frame: 12-24 weeks
Change in gait (walk)
25 foot Walk Test
Time frame: 12-36 weeks
Change in fine motor function
Pegboard test
Time frame: 12-24 weeks
Change in fine motor function
Pegboard test
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-36 weeks
Change in steps per day
Measured by accelerometer
Time frame: 12-24 weeks
Change in steps per day
Measured by accelerometer
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12-36 weeks