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Title: Effect of intermittent versus daily calorie restriction on changes in weight and patient reported outcomes in people with multiple sclerosis

Author
item FITZGERALD, KATHRYN - Johns Hopkins University
item VIZTHUM, DIANE - Johns Hopkins University
item HENRY-BARRON, BOBBIE - Johns Hopkins University
item SCHWEITZER, AMY - Johns Hopkins University
item CASSARD, SANDRA - Johns Hopkins University
item KOSSOFF, ERIC - Johns Hopkins University
item HARTMAN, A - Johns Hopkins University
item KAPOGIANNIS, DIMITRIOS - National Institutes Of Health (NIH)
item Sullivan, Patrick
item Baer, David
item MATTSON, MARK - National Institutes Of Health (NIH)
item APPEL, LAWRENCE - Johns Hopkins University
item MOWRY, ELLEN - Johns Hopkins University

Submitted to: Elsevier
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 5/4/2018
Publication Date: 5/5/2018
Citation: Fitzgerald, K.C., Vizthum, D., Henry-Barron, B., Schweitzer, A., Cassard, S.D., Kossoff, E., Hartman, A.L., Kapogiannis, D., Sullivan, P.J., Baer, D.J., Mattson, M., Appel, L.J., Mowry, E.M. 2018. Effect of intermittent versus daily calorie restriction on changes in weight and patient reported outcomes in people with multiple sclerosis. Journal of Multiple Sclerosis and Related Disorders. 23:33-39. https://doi.org/10.1016/j.msard.2018.05.002.
DOI: https://doi.org/10.1016/j.msard.2018.05.002

Interpretive Summary: Multiple sclerosis (MS) is a heterogeneous disease of the central nervous system, with a highly variable disease course. Currently, it is unclear as to why certain individuals experience relatively little disability progression while others accumulate substantial physical and cognitive disability. Reduction of calorie intake through daily restriction or through intermittent fasting are two approaches to reduce calorie intake. In mouse models of MS, both approaches have been shown to have favorable effects, and may provide additional anti-inflammatory and neuroprotective advantages beyond benefits obtained from weight loss alone. However, these approaches have not been tested in humans. The objective of this study was to assess safety and feasibility of different types of calorie restriction (CR) diets and assess their effects on weight and patient reported outcomes in people with MS. A randomized controlled feeding study of different types of CR diets vs. placebo in 36 people with MS. We recruited individuals aged 18-50 with relapsing-remitting MS that were stable on an injectable or not on any MS therapy and had a relapse or new lesion in the past 2 years. Patients were randomized to receive 1 of 3 diets for a period of 8 weeks: a daily CR diet (22% daily reduction in energy needs), an intermittent CR diet (75% reduction in calorie needs 2 days/week; 100% of daily needs 5 days/week), and a weight-stable diet (100% of daily calorie needs). Primary outcomes were safety and feasibility. Secondary outcomes were adherence to the dietary intervention and changes in body weight and patient-reported outcomes. Of the 36 patients enrolled, 31 (86%) completed the trial. There were no significant adverse events reported. Participants randomized to CR diets lost a median 7.4 lbs. Changes in weight did not differ significantly by type of CR diet, although participants randomized to daily CR tended to have greater weight loss. Adherence differed significantly between CR diets. Patients on either of the CR diets had a significant improvement in emotional well-being scores. In additional analysis of the data, changes of weight within an individual were positively associated with rates of improvements in emotional well-being and fatigue, and marginally with sleep quality. We found that CR diets are a safe and feasible way to achieve weight loss in people with MS and may be associated with improved emotional health and fatigue. Adherence is potentially stronger for daily CR when compared to intermittent CR. These preliminary data are of interest to health care providers treating patients with MS and to patients with MS who are interested in dietary strategies to manage their chronic disease.

Technical Abstract: An intermittent fasting or calorie restriction diet has favorable effects in the mouse forms of multiple sclerosis (MS) and may provide additional anti-inflammatory and neuroprotective advantages beyond benefits obtained from weight loss alone. We conducted a pilot randomized controlled feeding study in 36 people with MS to assess safety and feasibility of different types of calorie restriction (CR) diets and assess their effects on weight and patient reported outcomes in people with MS. Patients were randomized to receive 1 of 3 diets for 8 weeks: daily CR diet (22% daily reduction in energy needs), intermittent CR diet (75% reduction in energy needs, 2 days/week; 0% reduction, 5 days/week), or a weight-stable diet (0% reduction in energy needs, 7 days/week). Of the 36 patients enrolled, 31 (86%) completed the trial; no significant adverse events occurred. Participants randomized to CR diets lost a median 3.4'kg (interquartile range [IQR]: -2.4, -4.0). Changes in weight did not differ significantly by type of CR diet, although participants randomized to daily CR tended to have greater weight loss (daily CR: -3.6'kg [IQR: -3.0, -4.1] vs. intermittent CR: -3.0'kg [IQR: -1.95, -4.1]; P'='0.15). Adherence to study diets differed significantly between intermittent CR vs. daily CR, with lesser adherence observed for intermittent CR (P'='0.002). Randomization to either CR diet was associated with significant improvements in emotional well-being/depression scores relative to control, with an average 8-week increase of 1.69 points (95% CI: 0.72, 2.66). CR diets are a safe/feasible way to achieve weight loss in people with MS and may be associated with improved emotional health.