A randomized, controlled trial of low-fat diet for fatigue in multiple sclerosis (P6-3.008)

Abstract

<h3>Objective:</h3> Determine if a low-fat diet is effective at ameliorating fatigue in people with multiple sclerosis (PwMS) through a randomized controlled trial (RCT). Primary outcome is reduction in fatigue assessed via Modified Fatigue Impact Scale (MFIS) at 16 weeks. <h3>Background:</h3> Fatigue is a common, disabling symptom of multiple sclerosis (MS). A dietary intervention to improve fatigue is desirable given the minimal risk of adverse events. <h3>Design/Methods:</h3> PwMS were assigned to a low-fat diet (active) or wait-list (control) group. The active group received 4 weeks of data collection/nutrition counseling followed by adherence to the diet for 12 weeks. We measured diet adherence using monthly Food Frequency Questionnaire and 24-hr food recall. The principal statistical analysis used linear mixed models, with a random effect for subject to account for the within-subject correlation, in an intent-to-treat (ITT) framework to determine the effect of diet on the outcomes of MFIS and Fatigue Severity Scale (FSS). Sensitivity analysis was conducted by excluding potential outliers in both groups. <h3>Results:</h3> 39 participants were recruited with 20 in the active group and 19 in the control group. At baseline, participants’ mean age was 50 years (±12 years), mean BMI was 31 kg/m² (±7 kg/m²), and mean EDSS was 3.8 (±1.4). Mean MFIS decreased by −4.00 (95% CI: −12.04, 4.04) and mean FSS decreased by −0.41 (95% CI: −1.18, 0.36) from baseline to the end of the RCT in active group compared to control. Sensitivity analysis strengthened the magnitude of association with a mean MFIS decrease of −13.93 (95% CI: −20.65, −7.20) and mean FSS decrease of −1.22 (95% CI: −1.94, −0.50) in active group compared to control. Percent calories from fat decreased by 10.56% (95% CI: −18.50%, −2.97%) in active group compared to control. <h3>Conclusions:</h3> This 16-week long low-fat dietary intervention reduced the fatigue score significantly in the active group compared to controls. <b>Disclosure:</b> Dr. Chen has received research support from OHSU Foundation. Mrs. Chase has nothing to disclose. Dr. Lane has nothing to disclose. The institution of Dr. Wooliscroft has received research support from National Institutes of Health. Claire Adams has nothing to disclose. Mrs. Srikanth has nothing to disclose. Dr. Silbermann has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for Neurology. Dr. Silbermann has received research support from VA. Dr. Rice has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Greenwich Pharmaceuticals. Dr. Hollen has nothing to disclose. Allison Fryman has nothing to disclose. Dr. Martin has received research support from Tartar Trust. The institution of Dr. Martin has received research support from OHSU Foundation. Ms. Vong has nothing to disclose. Anna Orban has nothing to disclose. Dr. Khan has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Dompe Pharmaceuticals. The institution of Dr. Khan has received research support from United Therapeutics. The institution of Dr. Khan has received research support from Janssen pharmaceuticals. The institution of Dr. Khan has received research support from Eli Lilly. The institution of Dr. Khan has received research support from 4D Medical. The institution of Dr. Khan has received research support from Regeneron Pharmaceuticals. The institution of Dr. Khan has received research support from BOA Medical. Dr. Horgan has nothing to disclose. Dr. Yadav has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen Pharmaceuticals. Dr. Yadav has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bristol Myers Squibb Foundation. Dr. Yadav has received personal compensation in the range of $500-$4,999 for serving as a Consultant for EMD-Serono . The institution of Dr. Yadav has received research support from Department of Veterans Affairs. Dr. Yadav has received research support from NIH. Dr. Yadav has received research support from PCORI. Dr. Yadav has received research support from NMSS. The institution of Dr. Yadav has received research support from Department of Veterans Affairs. The institution of Dr. Yadav has received research support from Tykeson Family Foundation Endowed Professorship.