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K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy

This prospective open-label feasibility study aimed to evaluate acceptability, tolerability and compliance with dietary intervention with K.Vita, a medical food containing a unique ratio of decanoic acid to octanoic acid, in individuals with drug-resistant epilepsy. Adults and children aged 3–18 yea...

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Autores principales: Schoeler, Natasha E, Orford, Michael, Vivekananda, Umesh, Simpson, Zoe, Van de Bor, Baheerathi, Smith, Hannah, Balestrini, Simona, Rutherford, Tricia, Brennan, Erika, McKenna, James, Lambert, Bridget, Barker, Tom, Jackson, Richard, Williams, Robin S B, Sisodiya, Sanjay M, Eaton, Simon, Heales, Simon J R, Cross, J Helen, Walker, Matthew C
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8557697/
https://www.ncbi.nlm.nih.gov/pubmed/34729477
http://dx.doi.org/10.1093/braincomms/fcab160
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author Schoeler, Natasha E
Orford, Michael
Vivekananda, Umesh
Simpson, Zoe
Van de Bor, Baheerathi
Smith, Hannah
Balestrini, Simona
Rutherford, Tricia
Brennan, Erika
McKenna, James
Lambert, Bridget
Barker, Tom
Jackson, Richard
Williams, Robin S B
Sisodiya, Sanjay M
Eaton, Simon
Heales, Simon J R
Cross, J Helen
Walker, Matthew C
author_facet Schoeler, Natasha E
Orford, Michael
Vivekananda, Umesh
Simpson, Zoe
Van de Bor, Baheerathi
Smith, Hannah
Balestrini, Simona
Rutherford, Tricia
Brennan, Erika
McKenna, James
Lambert, Bridget
Barker, Tom
Jackson, Richard
Williams, Robin S B
Sisodiya, Sanjay M
Eaton, Simon
Heales, Simon J R
Cross, J Helen
Walker, Matthew C
author_sort Schoeler, Natasha E
collection PubMed
description This prospective open-label feasibility study aimed to evaluate acceptability, tolerability and compliance with dietary intervention with K.Vita, a medical food containing a unique ratio of decanoic acid to octanoic acid, in individuals with drug-resistant epilepsy. Adults and children aged 3–18 years with drug-resistant epilepsy took K.Vita daily whilst limiting high-refined sugar food and beverages. K.Vita was introduced incrementally with the aim of achieving ≤35% energy requirements for children or 240 ml for adults. Primary outcome measures were assessed by study completion, participant diary, acceptability questionnaire and K.Vita intake. Reduction in seizures or paroxysmal events was a secondary outcome. 23/35 (66%) children and 18/26 (69%) adults completed the study; completion rates were higher when K.Vita was introduced more gradually. Gastrointestinal disturbances were the primary reason for discontinuation, but symptoms were similar to those reported from ketogenic diets and incidence decreased over time. At least three-quarters of participants/caregivers reported favourably on sensory attributes of K.Vita, such as taste, texture and appearance, and ease of use. Adults achieved a median intake of 240 ml K.Vita, and children 120 ml (19% daily energy). Three children and one adult had ß-hydroxybutyrate >1 mmol/l. There was 50% (95% CI 39–61%) reduction in mean frequency of seizures/events. Reduction in seizures or paroxysmal events correlated significantly with blood concentrations of medium chain fatty acids (C10 and C8) but not ß-hydroxybutyrate. K.Vita was well accepted and tolerated. Side effects were mild and resolved with dietetic support. Individuals who completed the study complied with K.Vita and additional dietary modifications. Dietary intervention had a beneficial effect on frequency of seizures or paroxysmal events, despite absent or very low levels of ketosis. We suggest that K.Vita may be valuable to those with drug-resistant epilepsy, particularly those who cannot tolerate or do not have access to ketogenic diets, and may allow for more liberal dietary intake compared to ketogenic diets, with mechanisms of action perhaps unrelated to ketosis. Further studies of effectiveness of K.Vita are warranted.
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spelling pubmed-85576972021-11-01 K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy Schoeler, Natasha E Orford, Michael Vivekananda, Umesh Simpson, Zoe Van de Bor, Baheerathi Smith, Hannah Balestrini, Simona Rutherford, Tricia Brennan, Erika McKenna, James Lambert, Bridget Barker, Tom Jackson, Richard Williams, Robin S B Sisodiya, Sanjay M Eaton, Simon Heales, Simon J R Cross, J Helen Walker, Matthew C Brain Commun Original Article This prospective open-label feasibility study aimed to evaluate acceptability, tolerability and compliance with dietary intervention with K.Vita, a medical food containing a unique ratio of decanoic acid to octanoic acid, in individuals with drug-resistant epilepsy. Adults and children aged 3–18 years with drug-resistant epilepsy took K.Vita daily whilst limiting high-refined sugar food and beverages. K.Vita was introduced incrementally with the aim of achieving ≤35% energy requirements for children or 240 ml for adults. Primary outcome measures were assessed by study completion, participant diary, acceptability questionnaire and K.Vita intake. Reduction in seizures or paroxysmal events was a secondary outcome. 23/35 (66%) children and 18/26 (69%) adults completed the study; completion rates were higher when K.Vita was introduced more gradually. Gastrointestinal disturbances were the primary reason for discontinuation, but symptoms were similar to those reported from ketogenic diets and incidence decreased over time. At least three-quarters of participants/caregivers reported favourably on sensory attributes of K.Vita, such as taste, texture and appearance, and ease of use. Adults achieved a median intake of 240 ml K.Vita, and children 120 ml (19% daily energy). Three children and one adult had ß-hydroxybutyrate >1 mmol/l. There was 50% (95% CI 39–61%) reduction in mean frequency of seizures/events. Reduction in seizures or paroxysmal events correlated significantly with blood concentrations of medium chain fatty acids (C10 and C8) but not ß-hydroxybutyrate. K.Vita was well accepted and tolerated. Side effects were mild and resolved with dietetic support. Individuals who completed the study complied with K.Vita and additional dietary modifications. Dietary intervention had a beneficial effect on frequency of seizures or paroxysmal events, despite absent or very low levels of ketosis. We suggest that K.Vita may be valuable to those with drug-resistant epilepsy, particularly those who cannot tolerate or do not have access to ketogenic diets, and may allow for more liberal dietary intake compared to ketogenic diets, with mechanisms of action perhaps unrelated to ketosis. Further studies of effectiveness of K.Vita are warranted. Oxford University Press 2021-07-23 /pmc/articles/PMC8557697/ /pubmed/34729477 http://dx.doi.org/10.1093/braincomms/fcab160 Text en © The Author(s) (2021). Published by Oxford University Press on behalf of the Guarantors of Brain. https://creativecommons.org/licenses/by/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) ), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Schoeler, Natasha E
Orford, Michael
Vivekananda, Umesh
Simpson, Zoe
Van de Bor, Baheerathi
Smith, Hannah
Balestrini, Simona
Rutherford, Tricia
Brennan, Erika
McKenna, James
Lambert, Bridget
Barker, Tom
Jackson, Richard
Williams, Robin S B
Sisodiya, Sanjay M
Eaton, Simon
Heales, Simon J R
Cross, J Helen
Walker, Matthew C
K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy
title K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy
title_full K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy
title_fullStr K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy
title_full_unstemmed K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy
title_short K.Vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy
title_sort k.vita: a feasibility study of a blend of medium chain triglycerides to manage drug-resistant epilepsy
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8557697/
https://www.ncbi.nlm.nih.gov/pubmed/34729477
http://dx.doi.org/10.1093/braincomms/fcab160
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