Abstract
Objective: Assess the safety and tolerability of a ketogenic diet (KD) in patients with relapsing MS and secondarily explore the impact on patient-reported, laboratory and clinical outcome metrics.
Background: Dietary changes impact human physiology and immune function and have potential as therapeutic strategies in MS. Ketogenic diets mimic a fasting state and have been shown to impact immune regulation.
Design/Methods: 65 subjects with relapsing MS enrolled into a 6-month prospective KD intervention. Adherence to diet was monitored with the use of daily urine ketone testing. At baseline, patient-reported fatigue, depression and quality of life scores were obtained in addition to fasting adipokines and pertinent MS-related clinical outcome metrics. Baseline study metrics were repeated at 3 and/or 6 months on KD.
Results: 83% adhered to the KD for the full study period. Subjects exhibited reductions in fat mass from baseline to 6 months on-diet (41.3 ± 16.1 vs 32.0 ± 14.1 kg, p<0.001) and a significant decline in fatigue and depression scores. MS quality of life physical (67 ± 16 vs 79 ± 12, p<0.001) and mental (71 ± 17 vs 82 ± 11, p<0.001) composite scores improved on diet. Improvements were noted in EDSS scores (2.3 ± 0.9 vs 1.9 ± 1.1, p<0.001), 6-minute walk (1631 ± 302 vs 1733 ± 330 feet, p<0.001), and 9-hole peg test (21.5 ± 3.6 vs 20.3 ± 3.7 seconds, p<0.001). Fasting serum leptin was lower (25.5 ± 15.7 vs 14.0 ± 11.7 ng/mL, p<0.001) and adiponectin was higher at 6 months on KD (11.4 ± 7.8 vs 13.5 ± 8.4 mcg/mL, p=0.002).
Conclusions: KDs are safe and tolerable over a 6-month study period and yield improvements in body composition, fatigue, depression, quality of life, and neurologic disability in persons living with relapsing MS. KDs induce a reduction in pro-inflammatory adipokines and an elevation in anti-inflammatory adipokines.
Disclosure: The institution of Dr. Brenton has received research support from Integrated Translational Health Research Institute of Virginia. The institution of Dr. Brenton has received research support from NIH/NINDS. Diana Lehner-Gulotta has nothing to disclose. Emma Woolbright has nothing to disclose. Ms. Coleman has nothing to disclose. Mark Conaway has nothing to disclose. Dr. Banwell has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Banwell has received personal compensation in the range of $0-$499 for serving as a Consultant for UCB. Dr. Banwell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Roche. Dr. Banwell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Janssen. Dr. Banwell has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Medscape. Dr. Banwell has received personal compensation in the range of $0-$499 for serving as a Consultant for UTSW. Dr. Banwell has received personal compensation in the range of $0-$499 for serving on a Scientific Advisory or Data Safety Monitoring board for Novartis. The institution of Dr. Banwell has received research support from National MS Society. The institution of Dr. Banwell has received research support from NIH. Dr. Bergqvist has nothing to disclose. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for EMD Seronon. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Biogen, IDEC. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genzyme. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Genentec. Dr. Goldman has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for ADAMAS. Dr. Goldman has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Immunic. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Novartis Pharmceuticals. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Greenwich Biosciences. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Merk. Dr. Goldman has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Brainstorm Cell Therapeutics Ltd., .
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