Clinical trial NCT02914964: Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
Official title: Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Keywords: Fatigue
Quality of Life
Diet
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2016-09-26
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in participant perceived fatigue severity
timeFrame: 12-24 weeks
measure: Change in participant perceived fatigue severity
timeFrame: 12-36 weeks
measure: Change in the impact of fatigue on daily life
timeFrame: 12-24 weeks
measure: Change in the impact of fatigue on daily life
timeFrame: 12-36 weeks
Secondary outcomes:
measure: Change in participant walk speed
timeFrame: 12-24 weeks
measure: Change in participant walk speed
timeFrame: 12-36 weeks
measure: Change in gait (walk)
timeFrame: 12-24 weeks
measure: Change in gait (walk)
timeFrame: 12-36 weeks
measure: Change in fine motor function
timeFrame: 12-24 weeks
measure: Change in fine motor function
timeFrame: 12-36 weeks
measure: Change in nutrient intake based on the recommended daily allowance (RDA)
timeFrame: 12-24 weeks
measure: Change in nutrient intake based on the recommended daily allowance (RDA)
timeFrame: 12-36 weeks
measure: Change in cognitive function
timeFrame: 12-24 weeks
measure: Change in cognitive function
timeFrame: 12-36 weeks
measure: Change in steps per day
timeFrame: 12-24 weeks
measure: Change in steps per day
timeFrame: 12-36 weeks
measure: Change in participant Quality of Life (QoL) - General Health
timeFrame: 12-24 weeks
measure: Change in participant Quality of Life (QoL) - General Health
timeFrame: 12-36 weeks
measure: Change in participant Quality of Life (QoL) - Mental Health
timeFrame: 12-24 weeks
measure: Change in participant Quality of Life (QoL) - Mental Health
timeFrame: 12-36 weeks
measure: Change in total sleep time
timeFrame: 12-24 weeks
measure: Change in total sleep time
timeFrame: 12-36 weeks
measure: Change in perceived anxiety
timeFrame: 12-24 weeks
measure: Change in perceived anxiety
timeFrame: 12-36 weeks
measure: Change in perceived depression
timeFrame: 12-24 weeks
measure: Change in perceived depression
timeFrame: 12-36 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Terry L Wahls, MD, MBA
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Linda Snetselaar, PhD, RD,
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bisht B, Darling WG, Shivapour ET, Lutgendorf SK, Snetselaar LG, Chenard CA, Wahls TL. Multimodal intervention improves fatigue and quality of life in subjects with progressive multiple sclerosis: a pilot study. Degener Neurol Neuromuscul Dis. 2015;5:19-35. doi: 10.2147/DNND.S76523. Epub 2015 Feb 27.
citation: Bisht B, Darling WG, Grossmann RE, Shivapour ET, Lutgendorf SK, Snetselaar LG, Hall MJ, Zimmerman MB, Wahls TL. A multimodal intervention for patients with secondary progressive multiple sclerosis: feasibility and effect on fatigue. J Altern Complement Med. 2014 May;20(5):347-55. doi: 10.1089/acm.2013.0188. Epub 2014 Jan 29.
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citation: SWANK RL. Treatment of multiple sclerosis with low-fat diet: result of seven years' experience. Ann Intern Med. 1956 Nov;45(5):812-24. doi: 10.7326/0003-4819-45-5-812. No abstract available.
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citation: Swank RL, Goodwin JW. How saturated fats may be a causative factor in multiple sclerosis and other diseases. Nutrition. 2003 May;19(5):478. doi: 10.1016/s0899-9007(02)01099-7. No abstract available.
citation: Shemirani F, Titcomb TJ, Saxby SM, Eyck PT, Rubenstein LM, Hoth KF, Snetselaar LG, Wahls TL. Association of serum homocysteine, folate, and vitamin B12 and mood following the Swank and Wahls elimination dietary interventions in relapsing-remitting multiple sclerosis: Secondary analysis of the WAVES trial. Mult Scler Relat Disord. 2023 Jul;75:104743. doi: 10.1016/j.msard.2023.104743. Epub 2023 May 1.
citation: Crippes LJ, Saxby SM, Shemirani F, Bisht B, Gill C, Rubenstein LM, Ten Eyck P, Carr LJ, Darling WG, Hoth KF, Kamholz J, Snetselaar LG, Titcomb TJ, Wahls TL. Diet-induced changes in functional disability are mediated by fatigue in relapsing-remitting multiple sclerosis: A secondary analysis of the WAVES randomized parallel-arm trial. Mult Scler J Exp Transl Clin. 2023 Oct 30;9(4):20552173231209147. doi: 10.1177/20552173231209147. eCollection 2023 Oct-Dec.
citation: Villa AT, Tu BH, Titcomb TJ, Saxby SM, Shemirani F, Ten Eyck P, Rubenstein LM, Snetselaar LG, Wahls TL. Association between improved metabolic risk factors and perceived fatigue during dietary intervention trial in relapsing-remitting multiple sclerosis: A secondary analysis of the WAVES trial. Front Neurol. 2023 Jan 19;13:1022728. doi: 10.3389/fneur.2022.1022728. eCollection 2022.
citation: Wahls TL, Titcomb TJ, Bisht B, Eyck PT, Rubenstein LM, Carr LJ, Darling WG, Hoth KF, Kamholz J, Snetselaar LG. Impact of the Swank and Wahls elimination dietary interventions on fatigue and quality of life in relapsing-remitting multiple sclerosis: The WAVES randomized parallel-arm clinical trial. Mult Scler J Exp Transl Clin. 2021 Jul 31;7(3):20552173211035399. doi: 10.1177/20552173211035399. eCollection 2021 Jul-Sep.
citation: Wahls T, Scott MO, Alshare Z, Rubenstein L, Darling W, Carr L, Smith K, Chenard CA, LaRocca N, Snetselaar L. Dietary approaches to treat MS-related fatigue: comparing the modified Paleolithic (Wahls Elimination) and low saturated fat (Swank) diets on perceived fatigue in persons with relapsing-remitting multiple sclerosis: study protocol for a randomized controlled trial. Trials. 2018 Jun 4;19(1):309. doi: 10.1186/s13063-018-2680-x.