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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
SP
-
Sao Paulo, SP, Brasile, 01246-904
- Reclutamento
- Nagila Raquel Teixeira Damasceno
-
Contatto:
- Patricia Azevedo, PhD Student
- Numero di telefono: 1130617865
- Email: patricia.azlima@yahoo.com.br
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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 .
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: Group control
classical ketogenic diet
|
Ketogenic diet with high fat (90%)
|
|
Comparatore attivo: 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%)
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Socioeconomic and clinical profile
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Body Mass Index
Lasso di tempo: average of 3 months
|
BMI according growth charts
|
average of 3 months
|
|
Fat mass
Lasso di tempo: average of 3 months
|
Fat mass by impedance bioeletrical
|
average of 3 months
|
|
Fat free mass
Lasso di tempo: average of 3 months
|
fat free mass by impedance bioeletrical
|
average of 3 months
|
|
Phase angle
Lasso di tempo: average of 3 months
|
phase angle mass by impedance bioeletrical
|
average of 3 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Assessement of food intake
Lasso di tempo: average of 3 months
|
Food record applied during 3 days to each time
|
average of 3 months
|
|
Ketone bodies
Lasso di tempo: 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
Lasso di tempo: average of 3 months
|
Total cholesterol, LDL, HDL, TG
|
average of 3 months
|
|
NEFAS
Lasso di tempo: average of 3 months
|
Concentration in plasma.
Determination with kit NEFAS(Randox Laboratories Limited, Reino Unido)
|
average of 3 months
|
|
LDL oxidized
Lasso di tempo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
|
Antioxidant
Lasso di tempo: average of 3 months
|
Determination of antioxidant concentration in plasma by HPLC
|
average of 3 months
|
|
Metabolomic (lipidomic)
Lasso di tempo: average of 3 months
|
Determination in plasma by mass spectrometry
|
average of 3 months
|
|
Subfractions of Lipoproteins
Lasso di tempo: average of 3 months
|
Determination in plasma by Lipoprint
|
average of 3 months
|
|
Liver enzymes
Lasso di tempo: average of 3 months
|
Concentration of AST, ALT, GGT
|
average of 3 months
|
|
Hepatic function
Lasso di tempo: average of 3 months
|
Ultrasound liver
|
average of 3 months
|
|
Leptin
Lasso di tempo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
|
Resistin
Lasso di tempo: average of 3 months
|
Determination in plasma
|
average of 3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Mariana Baldini Prudencio, Master, Universidade of Sao Paulo
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Faculdade de Saúde Pública USP
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su ketogenic diet
-
Mondelēz International, Inc.KGK Science Inc.Completato
-
Hospital de Clinicas de Porto AlegreTerminatoPressione sanguignaBrasile
-
University of GlasgowCompletatoMorbo di Crohn | Modifica dieteticaRegno Unito
-
University of HawaiiNational Cancer Institute (NCI); National Institutes of Health (NIH); University...Reclutamento
-
Wolfson Medical CenterTerminatoColite ulcerosaIsraele, Francia, Italia
-
American University of Beirut Medical CenterReclutamentoObesità | Perdita di pesoLibano
-
Quadram Institute BioscienceUniversity of East Anglia; The Coca-Cola CompanyCompletato
-
University of CalgaryStewart Diabetes Education FundCompletatoObesità | Diabete mellito di tipo 2Canada
-
Vegenat, S.A.SconosciutoMorbo di Parkinson | Il morbo di Alzheimer | Demenza senileSpagna
-
International Centre for Diarrhoeal Disease Research...ReclutamentoBambini malnutritiBangladesh