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Impact of Ketogenic Diet on Lipoproteins in Refractory Epilepsy (Ketonutri)

28 december 2015 uppdaterad av: Patricia Azevedo de Lima, University of Sao Paulo

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

The ketogenic diet is a non-pharmacological treatment prescribed especially for children and indicated in most specialized centers for patients with refractory epilepsy. The composition of the ketogenic diet is based on high-fat, low-carbohydrate, moderate protein content, and the production of ketone bodies is the probable mechanism involved in the control of seizures. The relationship between the treatment of the ketogenic diet and changes in oxidative characteristics, physical and lipid are not well established. Some studies show a significant increase in total cholesterol and triglycerides in children being treated with ketogenic diet, but other studies have shown that changes in lipid profile in the long term do not appear to be significant, beyond the influence of these changes on coronary heart disease are unknown. The studies performed in the last two decades have shown that besides the changes in the lipid profile, oxidative modification of lipoproteins are essential for the initiation and progression of atherosclerosis and physical properties of lipoproteins also appear to be involved in this process, suggesting that the particle size of lipoproteins, through the analysis of subfractions can provide more details of the cardiovascular risk. Thus, this projetct aims to compare the effects of the classical ketogenic diet with the ketogenic diet modified with lower content of saturated fatty acids and a higher content of monounsaturated and polyunsaturated, the oxidative changes of LDL, lipidomic profile, the concentration of antioxidants in production inflammatory cytokines and the subfractions of LDL and HDL in children and adolescents with refractory epilepsy, the clinical effect on controlling epilepsy.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Förväntat)

60

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Brasilien
    • SP
      • Sao Paulo, SP, Brasilien, 01246-904
        • Rekrytering
        • Nagila Raquel Teixeira Damasceno
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

1 år till 19 år (Barn, Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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 .

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Enda

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Group control
classical ketogenic diet
Kosttillskott: ketogenic diet
Ketogenic diet with high fat (90%)
Aktiv komparator: 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
Kosttillskott: ketogenic diet
Ketogenic diet with high fat (90%)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Socioeconomic and clinical profile
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Body Mass Index
Tidsram: average of 3 months
BMI according growth charts
average of 3 months
Fat mass
Tidsram: average of 3 months
Fat mass by impedance bioeletrical
average of 3 months
Fat free mass
Tidsram: average of 3 months
fat free mass by impedance bioeletrical
average of 3 months
Phase angle
Tidsram: average of 3 months
phase angle mass by impedance bioeletrical
average of 3 months

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Assessement of food intake
Tidsram: average of 3 months
Food record applied during 3 days to each time
average of 3 months
Ketone bodies
Tidsram: 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
Tidsram: average of 3 months
Total cholesterol, LDL, HDL, TG
average of 3 months
NEFAS
Tidsram: average of 3 months
Concentration in plasma. Determination with kit NEFAS(Randox Laboratories Limited, Reino Unido)
average of 3 months
LDL oxidized
Tidsram: average of 3 months
Determination in plasma
average of 3 months
Antioxidant
Tidsram: average of 3 months
Determination of antioxidant concentration in plasma by HPLC
average of 3 months
Metabolomic (lipidomic)
Tidsram: average of 3 months
Determination in plasma by mass spectrometry
average of 3 months
Subfractions of Lipoproteins
Tidsram: average of 3 months
Determination in plasma by Lipoprint
average of 3 months
Liver enzymes
Tidsram: average of 3 months
Concentration of AST, ALT, GGT
average of 3 months
Hepatic function
Tidsram: average of 3 months
Ultrasound liver
average of 3 months
Leptin
Tidsram: average of 3 months
Determination in plasma
average of 3 months
Resistin
Tidsram: average of 3 months
Determination in plasma
average of 3 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Sao Paulo

Utredare

  • Studiestol: Mariana Baldini Prudencio, Master, Universidade of Sao Paulo

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 juni 2012

Primärt slutförande (Förväntat)

1 juli 2020

Avslutad studie (Förväntat)

1 juli 2020

Studieregistreringsdatum

Först inskickad

13 oktober 2015

Först inskickad som uppfyllde QC-kriterierna

28 december 2015

Första postat (Uppskatta)

31 december 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

31 december 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 december 2015

Senast verifierad

1 december 2015

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • Faculdade de Saúde Pública USP

Läkemedels- och apparatinformation, studiedokument

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