ABSTRACT
Background/Aims
Ketogenic diet therapies (KDTs) offer a needed therapeutic option for patients with drug-resistant epilepsy. The current study investigated biochemical and anthropometric indices of cardiovascular disease (CVD) risk in adults with epilepsy treated with KDT over 6 months.
Method
65 adults with epilepsy naïve to diet therapy were enrolled in a prospective longitudinal study and instructed on modified Atkins diet (MAD) use. Seizure frequency, anthropometric measures, blood levels of total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, apolipoproteins A1 and B, and lipoprotein sub-fractions were assessed at baseline, 3 months, and 6 months.
Results
Subsequent to study enrollment, 34 participants were lost to follow-up, elected not to start, or stopped MAD prior to study completion, leaving a total of 31 participants in the study at 6 months. Compared to baseline, participants on MAD showed significant reductions in median seizure frequency/week, weight, body mass index, waist and hip circumference, and percent body fat at 3 and 6 months. Compared to baseline, participants on MAD for 3 months showed significantly increased levels of total, small and medium LDL particles, ApoB and ApoB/A1 ratio. At 6 months, only small LDL particles and ApoB levels remained elevated and levels of ApoA1 had risen, suggesting possible compensatory adaptation over time.
Conclusions
This study provides evidence demonstrating the efficacy and cardiovascular safety of 6 months of MAD use by adults with epilepsy. It also highlights an index of CVD risk – small LDL particles - that should be closely monitored.
Trial registration: ClinicalTrials.gov identifier: NCT02694094..
Acknowledgements
The authors would like to acknowledge patients who participated in the study, Johns Hopkins Adult Epilepsy Diet Center Medical Office Coordinators Joanne Barnett and Corri Woodland, and nurse Rebecca Fisher. This study was funded by the generous philanthropic support from Chris Garrod and Dawn Griffiths and the Johns Hopkins KL2 Mentored Career Development Award (1 KL2 TR 3099-1).
Disclosure statement
Dr. McDonald has received speaking honoraria from Nutricia and support from the Johns Hopkins KL2 Mentored Career Development Award (1 KL2 TR 3099-1).Dr. Diaz-Arias has no conflicts of interest to disclose.Ms. Vizthum and Ms. Schlechter work within the Johns Hopkins Institute for Clinical and Translational Research (ICTR), which is funded in part by Grant Number UL1 TR003098 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research.Ms. Henry-Barron works within the Johns Hopkins Institute for Clinical and Translational Research (ICTR), which is funded in part by Grant Number UL1 TR003098 from the National Center for Advancing Translational Sciences (NCATS) a component of the National Institutes of Health (NIH), and NIH Roadmap for Medical Research. She has received support from Nutricia, Vitaflo, and The Carson Harris Foundation and personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nutricia, BioMarin, and Therachon, and has received royalties from Demos/Springer Publishing Company.Dr. Kossoff provides consulting services to Atkins Nutritionals, Inc., Nutricia, Vitaflo, Dr. Schar, and NeuroPace. He receives publishing royalties from Springer, UpToDate and Oxford Press. He is on the Data Safety Monitoring Boards for Bio-Pharm, Greenwich, and NIH. Dr. Cervenka has received support from The Epilepsy Foundation, The Johns Hopkins University School of Medicine Clinician Scientist Award, Nutricia, Vitaflo, The Glut1 Deficiency Foundation, The Carson Harris Foundation, Owens Family Foundation, Elaine Freeman and Johns Hopkins University Department of Neurosurgery, NIH (NINDS R01NS075020), and Army Research Laboratory. Dr. Cervenka has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nutricia. Dr. Cervenka has received royalties from Demos/Springer Publishing Company.
Additional information
Funding
Notes on contributors
Tanya J. W. McDonald
Tanya J. W. McDonald is an Assistant Professor of Neurology, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Luisa Diaz-Arias
Luisa Diaz-Arias is a Post-doctoral Research Fellow and Study Coordinator in the Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Diane Vizthum
Diane Vizthum is a Registered Dietitian and Research Nutritionist at the Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland, USA.
Bobbie J. Henry-Barron
Bobbie J. Henry-Barron is a Registered Dietitian and Research Nutritionist at the Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland, USA.
Haley Schlechter
Haley Schlechter is a Registered Dietitian and Research Nutritionist at the Institute for Clinical and Translational Research, Johns Hopkins University, Baltimore, Maryland, USA.
Eric H. Kossoff
Eric H. Kossoff is a Professor of Neurology and Pediatrics, Departments of Neurology and Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Mackenzie C. Cervenka
Mackenzie C. Cervenka is an Associate Professor of Neurology, Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.