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

Abstract

BackgroundFatigue 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/designThis 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:Observation: Participants continue eating their usual diet.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.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.DiscussionBecause 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 registrationClinicalTrials.gov, NCT02914964. Registered on 24 August 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2680-x) contains supplementary material, which is available to authorized users.

Nutrient Composition Comparison between a Modified Paleolithic Diet for Multiple Sclerosis and the Recommended Healthy U.S.-Style Eating Pattern

“…However, the shortfall was corrected by WahlsElim-prescribed supplementation with 125 µg vitamin D. Although this dose exceeds the 100 µg UL it is lower than the 250 µg (10,000 IU) dose recommended to correct low blood levels [85]. In the clinical study evaluating the WahlsElim diet [25], blood levels are measured so supplement dose can be titrated. Target blood level is 40–80 ng/mL based on studies correlating lowest disease activity with blood levels of >40 ng/mL [86].…”

“…No menus were available that met the WahlsElim diet guidelines. Therefore, seven-day Wahls™ menus, an earlier version of the WahlsElim diet, and associated recipes published in The Wahls Protocol: How I Beat Progressive MS Using Paleo Principles and Functional Medicine [13] were modified by a Registered Dietitian (RD) to meet WahlsElim diet guidelines provided by the diet’s author [25,56] (Table 2). Menus are shown in Supplementary Table S1.…”

“…The dietary guidelines are described in Table 1. A clinical trial of the WahlsElim diet is underway [25,26] and a review of the rationale for this diet was published [27].…”

Nutrient Composition Comparison between the Low Saturated Fat Swank Diet for Multiple Sclerosis and Healthy U.S.-Style Eating Pattern

“…One clinical trial currently underway is investigating the effect of the Swank diet on MS-related fatigue [61,62] but there are no reports of the Swank diet’s nutritional adequacy or compliance with the DGA. Swank considered his diet to be ‘healthy’ because of the reduction in fat and ‘junk’ food [36].…”

High Prudent diet factor score predicts lower relapse hazard in early multiple sclerosis

“…While there has long been interest in the impacts of specific diets in multiple sclerosis (MS) [1][2][3] , there have been few well-conducted studies with prospective collection of diet and disease progression measures. Due to the complexity of the human diet, and of its measurement, the study of diet is challenging.…”