Impact of Ketogenic Diet on Lipoproteins in Refractory Epilepsy

Not Applicable

• Conditions: Quality of Life; Non-alcoholic Fatty Liver Disease; Cardiovascular Disease; Epilepsy
• Interventions: Dietary Supplement: ketogenic diet

• Registration Number: NCT02644239
• Lead Sponsor: University of Sao Paulo

Brief Summary

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.

Detailed Description

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2015-10-13
• Status Verified: 2015-12
• Study First Submitted QC: 2015-12-28
• Last Update Submitted: 2015-12-28
• Study First Posted: 2015-12-31
• Last Update Posted: 2015-12-31
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 .

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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 .

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group control	ketogenic diet	classical ketogenic diet
Group case	ketogenic diet	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

Primary Outcome Measures

Name	Time	Method
Socioeconomic and clinical profile	average of 3 months	age, income, disease, parent´s education, use of drugs and supplements, type of seizures, questions about quality of life

Secondary Outcome Measures

Name	Time	Method
Body Mass Index	average of 3 months	BMI according growth charts
Fat mass	average of 3 months	Fat mass by impedance bioeletrical
Fat free mass	average of 3 months	fat free mass by impedance bioeletrical
Phase angle	average of 3 months	phase angle mass by impedance bioeletrical

Trial Locations

Locations (1)

Nagila Raquel Teixeira Damasceno; 🇧🇷 Sao Paulo, SP, Brazil