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

Terry Wahls, Maria O Scott, Zaidoon Alshare, Linda Rubenstein, Warren Darling, Lucas Carr, Karen Smith, Catherine A Chenard, Nicholas LaRocca, Linda Snetselaar, Terry Wahls, Maria O Scott, Zaidoon Alshare, Linda Rubenstein, Warren Darling, Lucas Carr, Karen Smith, Catherine A Chenard, Nicholas LaRocca, Linda Snetselaar

Abstract

Background: Fatigue is one of the most disabling symptoms of multiple sclerosis (MS) and contributes to diminishing quality of life. Although currently available interventions have had limited success in relieving MS-related fatigue, clinically significant reductions in perceived fatigue severity have been reported in a multimodal intervention pilot study that included a Paleolithic diet in addition to stress reduction, exercise, and electrical muscle stimulation. An optimal dietary approach to reducing MS-related fatigue has not been identified. To establish the specific effects of diet on MS symptoms, this study focuses on diet only instead of the previously tested multimodal intervention by comparing the effectiveness of two dietary patterns for the treatment of MS-related fatigue. The purpose of this study is to determine the impact of a modified Paleolithic and low saturated fat diet on perceived fatigue (primary outcome), cognitive and motor symptoms, and quality of life in persons with relapsing-remitting multiple sclerosis (RRMS).

Methods/design: This 36-week randomized clinical trial consists of three 12-week periods during which assessments of perceived fatigue, quality of life, motor and cognitive function, physical activity and sleep, diet quality, and social support for eating will be collected. The three 12-week periods will consist of the following: 1.

Observation: Participants continue eating their usual diet. 2.

Intervention: Participants will be randomized to a modified Paleolithic or low saturated fat diet for the intervention period. Participants will receive support from a registered dietitian (RD) through in-person coaching, telephone calls, and emails. 3.

Follow-up: Participants will continue the study diet for an additional 12 weeks with minimal RD support to assess the ability of the participants to sustain the study diet on their own.

Discussion: Because fatigue is one of the most common and disabling symptoms of MS, effective management and reduction of MS-related fatigue has the potential to increase quality of life in this population. The results of this study will add to the evidence base for providing dietary recommendations to treat MS-related fatigue and other symptoms associated with this disease.

Trial registration: ClinicalTrials.gov, NCT02914964 . Registered on 24 August 2016.

Keywords: Accelerometer; Diet; Fatigue; Intervention; Multiple sclerosis; Quality of life; Swank diet; Wahls elimination diet.

Conflict of interest statement

Ethics approval and consent to participate

Ethical approval was obtained from the University of Iowa Institutional Review Board (IRB identifier 201604705). Informed consent will be obtained from all study participants.

Competing interests

The University of Iowa has imposed a Conflict of Interest Management Plan on TW to ensure that the research is conducted without bias. The other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Dietary Approaches to Treat Multiple Sclerosis-Related Fatigue Study flowchart. MS Multiple sclerosis RRMS Relapsing-remitting multiple sclerosis
Fig. 2
Fig. 2
Standard Protocol Items: Recommendation for Interventional Trials (SPIRIT): the schedule of enrollment, interventions, and assessments. SPMSQ Short Portable Mental Status Questionnaire, FSS Fatigue Severity Scale, 9HPT 9-Hole Peg Test, T25FW Timed 25-foot walk, SDMT-O Symbol Digit Modalities Test–Oral, 6MWT 6-Minute walk test, MSQ Medical Symptoms Questionnaire, MFIS Modified Fatigue Impact Scale, MSQOL54 Multiple Sclerosis Quality of Life 54, FSMCF Fatigue Scale for Motor and Cognitive Function, MSIS v2 Multiple Sclerosis Impact Scale version 2, HADS Hospital Anxiety and Depression Scale, PSQI, PSS 10 Perceived Stress Scale 10, IPAQ-L International Physical Activity Questionnaire–Long, SF36 36-Item Short Form Health Survey, PDQ Perceived Deficits Questionnaire, MHI Mental Health Inventory, FFQ Food Frequency Questionnaire

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