Impact of Ketogenic Diet on Lipoproteins in Refractory Epilepsy (Ketonutri)
Classic Ketogenic Diet and Modified: Evaluation of the Therapeutic Potential and Impact on the Oxidative Profile, Lipidomic, Inflammatory and Size of Lipoproteins in Children and Adolescents With Refractory Epilepsy
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Controlled clinical trial composed of children of adolescents aged 1 to 19 years with refractory epilepsy drug polytherapy (antiepileptic drugs). Children of both sexes are being included. The control group receive the diet classical ketogenic while the case group receive the ketogenic diet modified reduction of at least 20% of the supply of saturated fat and increase> 50% of the acid supply monounsaturated fatty, increase> 50% of acid content polyunsaturated fatty and a lower ratio w6 / w3 at least 50% compared to classical diet used by the control group. Patients are followed in 3 times: baseline, 3 months and 6 months after the intervention.
Exclusion criteria: Children and adolescents who use any type of hormone replacement; Children and adolescents who present diagnosis of diabetes mellitus and hypothyroidism or hyperthyroidism; Children and adolescents with acute illnesses such as heart disease and kidney disease that prevent indication of the DC evaluated by medical history and complete physical examination by the neurologist doctor in charge of the clinic.
Outcome Measures:
a. Characterize the sample as the demographics (gender, age), scioeconomic, quality of life and clinical; B. To assess dietary intake through food records; c. Evaluate the anthropometric profile and classify the nutritional status (Z score of body mass index for age [ZBMI / I]); d. Assess body composition (percentage of fat, lean mass, total body water and phase angle); e. Determine the concentration of cholesterol and triglycerides, lipoproteins (TC, TG, LDL and HDL); f. Determine the concentration of apolipoproteins: APOA-1 and APO-B; g. Detect the concentration of ketone bodies in the plasma (β-hydroxybutyrate); H. Detecting LDL (-) and oxidized LDL in plasma; i. To detect anti-LDL autoantibodies (-) and anti-oxLDL autoantibodies in plasma; j. Determine subfractions HDL, LDL and high LDL particle size; k. To evaluate the concentration of non-esterified fatty acids (NEFAs); l. Assess the concentration of fatty acids in plasma; m. To assess the concentration of substances reactive to thiobarbituric acid (TBARS) in plasma.
n. Determine the concentration of antioxidants in plasma: α-tocopherol, beta-carotene and retinol.
O. Determining the lipidomic plasma profile gathering lipid species in more classes associated with the risk of cardiovascular disease; P. Detecting inflammatory markers: Tumor necrosis factor (TNF-α), interleukin (IL-6) in plasma.
Q. Determine the concentration of hepatic enzymes R. Determine the leptin, adiponectin, ghrelin and resistin S. To evaluate the liver ultrasound and carotid ultrasound
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
SP
-
Sao Paulo, SP, Brasil, 01246-904
- Recrutamento
- Nagila Raquel Teixeira Damasceno
-
Contato:
- Patricia Azevedo, PhD Student
- Número de telefone: 1130617865
- E-mail: patricia.azlima@yahoo.com.br
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria: Participate in the study children and adolescents of both sexes with age 1-19 years diagnosed with refractory epilepsy drug polytherapy ( antiepileptic drugs ) and indication of treatment with KD .
-
Exclusion Criteria: Children and adolescents who use any type of hormonal replacement ;
- Children and adolescents who submit diagnosis of diabetes mellitus and hypothyroidism or hyperthyroidism ;
- Children and adolescents showing acute disorders as heart disease and kidney diseases .
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Group control
classical ketogenic diet
|
Ketogenic diet with high fat (90%)
|
|
Comparador Ativo: Group case
Group case: modified ketogenic diet to reduce at least 20% saturated fat, up> 50% of the acid supply monounsaturated, increasing> 50% polyunsaturated fatty acid content and a lower ratio w6 / w3 at least 50% compared to classic diet used by the control group
|
Ketogenic diet with high fat (90%)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Socioeconomic and clinical profile
Prazo: average of 3 months
|
age, income, disease, parent´s education, use of drugs and supplements, type of seizures, questions about quality of life
|
average of 3 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Body Mass Index
Prazo: average of 3 months
|
BMI according growth charts
|
average of 3 months
|
|
Fat mass
Prazo: average of 3 months
|
Fat mass by impedance bioeletrical
|
average of 3 months
|
|
Fat free mass
Prazo: average of 3 months
|
fat free mass by impedance bioeletrical
|
average of 3 months
|
|
Phase angle
Prazo: average of 3 months
|
phase angle mass by impedance bioeletrical
|
average of 3 months
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Assessement of food intake
Prazo: average of 3 months
|
Food record applied during 3 days to each time
|
average of 3 months
|
|
Ketone bodies
Prazo: average of 3 months
|
Concentration of B-hydroxybutirate in plasma.
Determination with kit Ranbut (Randox Laboratories Limited, Reino Unido).
|
average of 3 months
|
|
Lipid profile
Prazo: average of 3 months
|
Total cholesterol, LDL, HDL, TG
|
average of 3 months
|
|
NEFAS
Prazo: average of 3 months
|
Concentration in plasma.
Determination with kit NEFAS(Randox Laboratories Limited, Reino Unido)
|
average of 3 months
|
|
LDL oxidized
Prazo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
|
Antioxidant
Prazo: average of 3 months
|
Determination of antioxidant concentration in plasma by HPLC
|
average of 3 months
|
|
Metabolomic (lipidomic)
Prazo: average of 3 months
|
Determination in plasma by mass spectrometry
|
average of 3 months
|
|
Subfractions of Lipoproteins
Prazo: average of 3 months
|
Determination in plasma by Lipoprint
|
average of 3 months
|
|
Liver enzymes
Prazo: average of 3 months
|
Concentration of AST, ALT, GGT
|
average of 3 months
|
|
Hepatic function
Prazo: average of 3 months
|
Ultrasound liver
|
average of 3 months
|
|
Leptin
Prazo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
|
Resistin
Prazo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Mariana Baldini Prudencio, Master, Universidade of Sao Paulo
Publicações e links úteis
Publicações Gerais
- Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
- Avogaro P, Bon GB, Cazzolato G. Presence of a modified low density lipoprotein in humans. Arteriosclerosis. 1988 Jan-Feb;8(1):79-87. Erratum In: Arteriosclerosis 1988 Nov-Dec;8(6):857.
- Avogaro P, Cazzolato G, Bittolo-Bon G. Some questions concerning a small, more electronegative LDL circulating in human plasma. Atherosclerosis. 1991 Nov;91(1-2):163-71. doi: 10.1016/0021-9150(91)90198-c.
- Faulin Tdo E, de Sena-Evangelista KC, Pacheco DB, Augusto EM, Abdalla DS. Development of immunoassays for anti-electronegative LDL autoantibodies and immune complexes. Clin Chim Acta. 2012 Jan 18;413(1-2):291-7. doi: 10.1016/j.cca.2011.10.004. Epub 2011 Oct 18.
- Fisher RS, van Emde Boas W, Blume W, Elger C, Genton P, Lee P, Engel J Jr. Epileptic seizures and epilepsy: definitions proposed by the International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE). Epilepsia. 2005 Apr;46(4):470-2. doi: 10.1111/j.0013-9580.2005.66104.x.
- Freeman JM, Kossoff EH, Hartman AL. The ketogenic diet: one decade later. Pediatrics. 2007 Mar;119(3):535-43. doi: 10.1542/peds.2006-2447.
- Kossoff EH, Zupec-Kania BA, Amark PE, Ballaban-Gil KR, Christina Bergqvist AG, Blackford R, Buchhalter JR, Caraballo RH, Helen Cross J, Dahlin MG, Donner EJ, Klepper J, Jehle RS, Kim HD, Christiana Liu YM, Nation J, Nordli DR Jr, Pfeifer HH, Rho JM, Stafstrom CE, Thiele EA, Turner Z, Wirrell EC, Wheless JW, Veggiotti P, Vining EP; Charlie Foundation, Practice Committee of the Child Neurology Society; Practice Committee of the Child Neurology Society; International Ketogenic Diet Study Group. Optimal clinical management of children receiving the ketogenic diet: recommendations of the International Ketogenic Diet Study Group. Epilepsia. 2009 Feb;50(2):304-17. doi: 10.1111/j.1528-1167.2008.01765.x. Epub 2008 Sep 23.
- Kwiterovich PO Jr, Vining EP, Pyzik P, Skolasky R Jr, Freeman JM. Effect of a high-fat ketogenic diet on plasma levels of lipids, lipoproteins, and apolipoproteins in children. JAMA. 2003 Aug 20;290(7):912-20. doi: 10.1001/jama.290.7.912.
- Lee PR, Kossoff EH. Dietary treatments for epilepsy: management guidelines for the general practitioner. Epilepsy Behav. 2011 Jun;21(2):115-21. doi: 10.1016/j.yebeh.2011.03.008. Epub 2011 Apr 21.
- Libby P, Ridker PM, Hansson GK; Leducq Transatlantic Network on Atherothrombosis. Inflammation in atherosclerosis: from pathophysiology to practice. J Am Coll Cardiol. 2009 Dec 1;54(23):2129-38. doi: 10.1016/j.jacc.2009.09.009.
- Liu YM, Williams S, Basualdo-Hammond C, Stephens D, Curtis R. A prospective study: growth and nutritional status of children treated with the ketogenic diet. J Am Diet Assoc. 2003 Jun;103(6):707-12. doi: 10.1053/jada.2003.50136.
- WHO Multicentre Growth Reference Study Group. WHO Child Growth Standards based on length/height, weight and age. Acta Paediatr Suppl. 2006 Apr;450:76-85. doi: 10.1111/j.1651-2227.2006.tb02378.x.
- de Onis M, Onyango AW, Borghi E, Siyam A, Nishida C, Siekmann J. Development of a WHO growth reference for school-aged children and adolescents. Bull World Health Organ. 2007 Sep;85(9):660-7. doi: 10.2471/blt.07.043497.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Faculdade de Saúde Pública USP
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
produto fabricado e exportado dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em ketogenic diet
-
George Washington UniversityAtivo, não recrutandoAmamentaçãoEstados Unidos
-
Mondelēz International, Inc.KGK Science Inc.ConcluídoExcesso de pesoEstados Unidos
-
The University of Texas Health Science Center at...ConcluídoTranstorno de Déficit de Atenção com HiperatividadeEstados Unidos
-
Icahn School of Medicine at Mount SinaiUniversity of Massachusetts, Worcester; The Leona M. and Harry B. Helmsley Charitable...Ativo, não recrutandoGravidez | Doença de CrohnEstados Unidos
-
University of HullConcluído
-
Rockefeller UniversityConcluídoDistúrbio do Metabolismo da GlicoseEstados Unidos
-
Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital SystemRecrutamentoDerrame | Demência | Doença de Alzheimer | Demência Vascular | Declínio CognitivoEstados Unidos
-
International Centre for Diarrhoeal Disease Research...International Atomic Energy Agency; HarvestPlusConcluído
-
University of PittsburghConcluídoDoenças cardiovasculares | ObesidadeEstados Unidos
-
Hospital de Clinicas de Porto AlegreRescindidoPressão arterialBrasil