RANDOMIZED CONTROLLED TRIAL OF INTERMITTENT CALORIE RESTRICTION IN PEOPLE WITH MULTIPLE SCLEROSIS

Abstract

ABSTRACTBackgroundCalorie restriction (CR) ameliorates preclinical models of multiple sclerosis (MS) through reduction of inflammation. The aim of this trial was to study the effects of 12-week iCR on metabolic, immunological and clinical outcomes in people with MS (pwMS).MethodsParticipants with relapsing-remitting MS were randomly assigned to intermittent CR (iCR) or a control group for 12 weeks. Primary outcome was change in leptin levels; secondary outcomes included changes in anthropometric and body composition measures, peripheral blood metabolic and immunologic profiling, and clinical measures. Mixed effects linear regression models were used to evaluate differences.ResultsForty-two pwMS were randomized, 34 completed the study (17 iCR and 17 control). Leptin levels decreased in the iCR group and were significantly lower in the iCR than the control group at 6 (mean difference 11.49 mg/dL, 95% CI 32.54, 9.54;P=0.01) and 12 weeks (6.97 mg/dL, 95% CI 28.02, 14.06;P=0.03). We observed a significant reduction of weight, body mass index and body adiposity measures over the 6 and 12-weeks in the iCR group. Immune profiling showed a significant increase in CD45RO+regulatory T cell numbers after 6 weeks of iCR. Lysophosphatidylcholine, lysophophatidylethanolamine and phosphatidylinositol lipid species were significantly increased after 12 weeks in the iCR group compared to baseline, and all three were higher at 12 weeks compared to controls. Exploratory cognitive testing demonstrated improvement in the symbol digit modality test score in the iCR group.ConclusionsShort term iCR is safe, feasible and can benefit metabolic and immunologic profiles in pwMS.ClinicalTrial.gov number:NCT03539094(first patient screened on 11/14/17; first patient recruited on 1/29/2018; last patient recruited on 11/24/2021).