Impact of Ketogenic Diet on Lipoproteins in Refractory Epilepsy
Parole chiave
Astratto
Descrizione
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
Date
| Ultimo verificato: | 11/30/2015 |
| Primo inviato: | 10/12/2015 |
| Iscrizione stimata inviata: | 12/27/2015 |
| Primo pubblicato: | 12/30/2015 |
| Ultimo aggiornamento inviato: | 12/27/2015 |
| Ultimo aggiornamento pubblicato: | 12/30/2015 |
| Data di inizio effettiva dello studio: | 05/31/2012 |
| Data di completamento primaria stimata: | 06/30/2020 |
| Data stimata di completamento dello studio: | 06/30/2020 |
Condizione o malattia
Intervento / trattamento
Dietary Supplement: ketogenic diet
Fase
Gruppi di braccia
| Braccio | Intervento / trattamento |
|---|---|
| Active Comparator: Group control classical ketogenic diet | |
| Active Comparator: 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 |
Criteri di idoneità
| Età idonea per lo studio | 1 Year Per 1 Year |
| Sessi idonei allo studio | All |
| Accetta volontari sani | sì |
| Criteri | 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 . |
Risultato
Misure di esito primarie
1. Socioeconomic and clinical profile [average of 3 months]
Misure di esito secondarie
1. Body Mass Index [average of 3 months]
2. Fat mass [average of 3 months]
3. Fat free mass [average of 3 months]
4. Phase angle [average of 3 months]
Altre misure di risultato
1. Assessement of food intake [average of 3 months]
2. Ketone bodies [average of 3 months]
3. Lipid profile [average of 3 months]
4. NEFAS [average of 3 months]
5. LDL oxidized [average of 3 months]
6. Antioxidant [average of 3 months]
7. Metabolomic (lipidomic) [average of 3 months]
8. Subfractions of Lipoproteins [average of 3 months]
9. Liver enzymes [average of 3 months]
10. Hepatic function [average of 3 months]
11. Leptin [average of 3 months]
12. Resistin [average of 3 months]
