Introduction
Fatigue is defined as “a subjective lack of physical and/or mental energy that is perceived by the individual or caregiver to interfere with usual or desired activities” [1]. Fatigue is a frequent and debilitating multiple sclerosis (MS) symptom [2]. Estimates of its prevalence range from 52% to 93% [3]. Fatigue affects MS patients’ quality of life independently of disability [4] and adversely affects their ability to work full-time.
The etiology of MS fatigue is considered multifactorial [5]. Fatigue can result from MS pathobiological processes, which cause blood-brain barrier breakdown, central nervous system inflammation, demyelination, lesion formation and neurodegeneration [5]. Fatigue can also include contributions from co-morbidities such as depression, physical and emotional stress and external factors, e.g., poor diet and lack of sleep [5]. However, MS fatigue appears to be a distinct clinical entity that differs from other causes of fatigue such as disability and depression [2].
Pharmacological options for treating MS-associated fatigue are limited. Patients are commonly prescribed modafinil or amantadine; fluoxetine is sometimes prescribed off-label. Anti-fatigue drugs have stimulant activity and are often associated with side effects. There is support for non-pharmacological options such as exercise, physical therapy with vestibular rehabilitation and cognitive behavioral therapy [6].
Some dietary interventions have shown promise for treating MS fatigue [7–10]. Yadav et al. showed that fatigue outcome measures were improved in relapsing-remitting MS patients on a very-low-fat, plant-based diet [7]. We previously reported that diet-based multimodal intervention supplemented with exercise, neuromuscular electrical stimulation (NMES) and stress reduction techniques was effective at reducing fatigue in progressive MS patients [8–10]. The study diet recommended high intake of vegetables and fruits, encouraged consumption of animal and plant protein and excluded foods with gluten-containing grains, dairy and eggs. However, the physiological mechanisms underlying the effectiveness of this multimodal intervention on fatigue are not known.
The associations between diet and lipid parameters have become delineated in recent meta-analyses conducted in the context of cardiovascular disease [11, 12]. The replacement of saturated fat by polyunsaturated and monounsaturated fats decreases TC, LDL-C and TG, whereas replacement of saturated fats by carbohydrates decreases TC and LDL-C, but increases TG. Saturated fat decreases and polyunsaturated fat increases the anti-inflammatory activity of HDL-C [13]. Replacing saturated fat with polyunsaturated or monounsaturated fat lowers HDL-C slightly. However, replacement with carbohydrates lowers HDL-C to a greater extent [12, 14].
Our working hypothesis that lipid and cholesterol pathways could be potential mediators of the effects of the study diet on fatigue was motivated by two factors. First, the study diet alters food macronutrient composition, which could affect metabolism, causing changes in lipid and cholesterol profiles. Second, an emerging body of evidence has demonstrated that metabolic changes [15, 16] underlie the immune and neurodegenerative pathophysiological processes of MS and that cholesterol biomarkers are associated with brain injury and disease progression in MS [17–21]. However, the roles, if any, of lipid and cholesterol pathways in MS fatigue have not been investigated.
The aims of this study were to characterize the changes in lipid and cholesterol biomarkers during the diet-based multimodal intervention and to investigate whether these biomarkers were associated with fatigue outcomes. We analyzed data obtained from a Phase 1 pilot trial of an integrative diet-based multimodal intervention (study diet, exercise, NMES, stress reduction) on fatigue in progressive MS patients. The aims of the trial were to assess the safety, patient adherence to the diet and other components of the study, effects and nutritional adequacy of the study diet for MS fatigue.
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