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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
SP
-
Sao Paulo, SP, Brasil, 01246-904
- Reclutamiento
- Nagila Raquel Teixeira Damasceno
-
Contacto:
- Patricia Azevedo, PhD Student
- Número de teléfono: 1130617865
- Correo electrónico: patricia.azlima@yahoo.com.br
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 .
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Group control
classical ketogenic diet
|
Ketogenic diet with high fat (90%)
|
|
Comparador activo: 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%)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Socioeconomic and clinical profile
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Body Mass Index
Periodo de tiempo: average of 3 months
|
BMI according growth charts
|
average of 3 months
|
|
Fat mass
Periodo de tiempo: average of 3 months
|
Fat mass by impedance bioeletrical
|
average of 3 months
|
|
Fat free mass
Periodo de tiempo: average of 3 months
|
fat free mass by impedance bioeletrical
|
average of 3 months
|
|
Phase angle
Periodo de tiempo: average of 3 months
|
phase angle mass by impedance bioeletrical
|
average of 3 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessement of food intake
Periodo de tiempo: average of 3 months
|
Food record applied during 3 days to each time
|
average of 3 months
|
|
Ketone bodies
Periodo de tiempo: 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
Periodo de tiempo: average of 3 months
|
Total cholesterol, LDL, HDL, TG
|
average of 3 months
|
|
NEFAS
Periodo de tiempo: average of 3 months
|
Concentration in plasma.
Determination with kit NEFAS(Randox Laboratories Limited, Reino Unido)
|
average of 3 months
|
|
LDL oxidized
Periodo de tiempo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
|
Antioxidant
Periodo de tiempo: average of 3 months
|
Determination of antioxidant concentration in plasma by HPLC
|
average of 3 months
|
|
Metabolomic (lipidomic)
Periodo de tiempo: average of 3 months
|
Determination in plasma by mass spectrometry
|
average of 3 months
|
|
Subfractions of Lipoproteins
Periodo de tiempo: average of 3 months
|
Determination in plasma by Lipoprint
|
average of 3 months
|
|
Liver enzymes
Periodo de tiempo: average of 3 months
|
Concentration of AST, ALT, GGT
|
average of 3 months
|
|
Hepatic function
Periodo de tiempo: average of 3 months
|
Ultrasound liver
|
average of 3 months
|
|
Leptin
Periodo de tiempo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
|
Resistin
Periodo de tiempo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Mariana Baldini Prudencio, Master, Universidade of Sao Paulo
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Faculdade de Saúde Pública USP
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre ketogenic diet
-
Mondelēz International, Inc.KGK Science Inc.Terminado
-
University of CalgaryStewart Diabetes Education FundTerminadoObesidad | Diabetes mellitus tipo 2Canadá
-
Vegenat, S.A.DesconocidoEnfermedad de Parkinson | Enfermedad de alzheimer | Demencia senilEspaña
-
Vegenat, S.A.DesconocidoNutrición enteral | Pancreatitis agudaEspaña
-
University of California, DavisUSDA, Western Human Nutrition Research CenterReclutamiento
-
International Centre for Diarrhoeal Disease Research...ReclutamientoNiños desnutridosBangladesh
-
Centre Hospitalier Universitaire de NīmesReclutamiento
-
Hospital de Clinicas CaracasDesconocidoSíndrome de ovario poliquístico (SOP) MujeresVenezuela