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

Would the exact same diet protocol help in stroke fatigue? We'll never know since we have NO stroke leadership that follows up interesting research that might help stroke recovery. You, your children and grandchildren are screwed until stroke survivors run the stroke associations.
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2680-x

• Terry WahlsEmail authorView ORCID ID profile,
• Maria O. Scott,
• Zaidoon Alshare,
• Linda Rubenstein,
• Warren Darling,
• Lucas Carr,
• Karen Smith,
• Catherine A. Chenard,
• Nicholas LaRocca and
• Linda Snetselaar

Trials201819:309

https://doi.org/10.1186/s13063-018-2680-x

©  The Author(s). 2018

Received: 21 December 2017

Accepted: 8 May 2018

Published: 4 June 2018

Open Peer Review reports

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. 1.
   Observation: Participants continue eating their usual diet.
2. 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. 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

Multiple sclerosisFatigueDietAccelerometerQuality of lifeInterventionSwank dietWahls elimination diet

Background

Fatigue is one of the most common and disabling symptoms of multiple sclerosis (MS), diminishing quality of life (QOL) and contributing to early exit from the workforce [1, 2]. MS-related fatigue is most commonly managed through multiple interventions, including disease-modifying drugs and stimulants, exercise, energy conservation, and stress management techniques [3]. Although exercise augmented by electrical muscle stimulation can be modestly effective in reducing perceived fatigue [4, 5], studies investigating the efficacy of pharmaceutical therapies have shown conflicting results [6, 7, 8]. Because drug treatment has not been effective, dietary interventions are being explored. Statistically and clinically significant reductions in perceived fatigue severity in persons with progressive multiple sclerosis (pwPMS) have been reported with use of a multimodal intervention consisting of a modified Paleolithic diet, stress reduction, exercise, and electrical muscle stimulation [4, 5].

Interventions considering the whole diet (vs. supplement-based, single-nutrient focus) have been used in treating or preventing diseases, including psoriasis [9], cancer [10, 11], and neurological diseases [12]. Emerging data support the notion that environmental rather than genetic factors are likely the predominant causes of MS [13]. Given that food consumed is a major component of the environment, it is conceivable that improving the quality of the diet may have a significant impact on the development of MS. The relationship between the quality of the diet and MS-related symptoms such as fatigue is unknown. In this study, we will compare two dietary patterns for the treatment of MS-related fatigue: the modified Paleolithic diet (Wahls elimination diet) and a low saturated fat diet (Swank diet).

One early dietary intervention for individuals with MS was based on the observation that high levels of saturated fat in the diet were associated with increased risk for MS in Norway [14, 15]. Dr. Roy Swank theorized that a diet high in saturated fats causes more rapid disease progression. Dr. Swank followed 144 patients with mild to more severe disability for 34 years. These individuals had agreed to consume a diet containing < 20 g of saturated fat per day and report their dietary adherence. The patients’ clinical outcomes were monitored, including physical and mental performance [16, 17, 18, 19, 20, 21]. The Swank study found that the number of relapses and progression of disability was associated strongly with dietary saturated fat consumption [17, 18, 19, 20, 21, 22]. The 50-year follow-up is a strength of the Swank study, but the absence of a control group and lack of brain imaging are limitations.

Consumption of vegetables has also been associated with favorable health outcomes related to MS. Notably, the mean daily serving of vegetables is associated with lower risk of developing obesity [23], which is a risk factor for and a common comorbid diagnosis of those with MS. Increased consumption of vegetables is associated with lower Expanded Disability Status Scale scores [24], insulin sensitivity, blood pressure, body weight, and body mass index (BMI). Considering these observations, researchers in a more recent randomized controlled trial used a vegetarian version of the Swank diet [25], also known as the McDougall diet. Measures included the Fatigue Severity Scale (FSS), 36-item Short Form Health Survey (SF-36) quality-of-life scores, lipids, weight, BMI, and brain magnetic resonance imaging (MRI) scans at baseline and at 1 year [26]. Favorable reductions in weight, BMI, and total cholesterol were observed, but no statistically significant differences in MRI findings or SF-36 quality-of-life scores were reported [26].

Another diet of interest to the MS community is a Paleolithic diet [27]. Dr. Loren Cordain’s recommendations for a modern version of the Paleolithic diet stresses the consumption of meats, vegetables, and fruits; excludes grains, legumes, and dairy [27, 28]; and excludes nightshade vegetables (potatoes, tomatoes, peppers, and eggplants) [29] for persons with rheumatoid arthritis. Recently tested for its impact on various biomarkers in healthy individuals, the Paleolithic diet was associated with improvements in blood pressure, BMI [30], total cholesterol, insulin sensitivity, fasting insulin, and arterial distensibility [31]. In a study of patients with type 2 diabetes, the Paleolithic diet was shown to be more satiating per calorie than the American Diabetes Association (ADA) diet, which encourages increased intake of vegetables, dietary fiber, whole-grain bread and cereal products, fruits, and berries and decreased intake of total fat with more unsaturated fat [32]. In a crossover study comparing the Paleolithic diet with the ADA diet, the Paleolithic diet was superior to the ADA diet with respect to improving blood pressure, lipid profile, and glycemic control [33]. Finally, in a randomized controlled study of obese persons with metabolic syndrome, comparison of the Paleolithic diet with the control diet, which was an isoenergetic diet based on Dutch dietary guidelines, the Paleolithic diet was associated with greater improvements in blood pressure, fasting levels of lipids, and weight loss than the control diet [34].

A modified version of the Paleolithic diet was shown to reduce perceived fatigue in pwPMS (either secondary or primary progressive multiple sclerosis [SPMS or PPMS, respectively]) [4, 5] as part of a multimodal intervention (modified Paleolithic diet, targeted vitamin supplementation, stress-reducing practices, exercise, and electrical muscle stimulation). The study diet stressed the consumption of more vegetables, with a target of 6 to 9 cups of vegetables and fruit per day, and recommended somewhat less meat than Paleolithic diets tested in the previously mentioned studies. At enrollment, study participants were consuming less than 1.5 servings of vegetables per day but raised this to an average of 8 servings per day by month 12 [5]. The dietary component of the multimodal intervention was significantly associated with favorable changes in mood and cognition between baseline and 12 months, whereas the nondietary components were not [25]. It is unknown whether the dietary component of the multimodal intervention also significantly contributed to the observed reduction in perceived fatigue [4, 5]; however, several participants anecdotally reported that deviations from the study diet resulted in a sharp worsening of their fatigue and noted that the fatigue resolved with stricter adherence to the study diet. Data from another pilot randomized controlled trial also showed significant reductions in perceived fatigue (as assessed by FSS) in individuals with relapsing-remitting multiple sclerosis (RRMS) following a modified Paleolithic diet intervention [35].

To establish the specific effects of diet on MS symptoms such as fatigue, this study focuses on diet only instead of the previously tested multimodal intervention. The modified Paleolithic diet continues to stress a high intake of vegetables but also eliminates foods to which some individuals may be sensitive: eggs and nightshade vegetables [29]. To enhance adherence and reduce the rate of dropout, which occurred early in the intervention among participants in a nondiet control group [35], control participants will be assigned a second diet, a low saturated fat (Swank) diet, which is also popular among the MS community and has research to support its efficacy.

Study design at the link.