此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

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

2015年12月28日 更新者: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.

研究概览

详细说明

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

研究类型

介入性

注册 (预期的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • SP
      • Sao Paulo、SP、巴西、01246-904
        • 招聘中
        • Nagila Raquel Teixeira Damasceno
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

1年 至 19年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

描述

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 .

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Group control
classical ketogenic diet
Ketogenic diet with high fat (90%)
有源比较器: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%)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Socioeconomic and clinical profile
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Body Mass Index
大体时间:average of 3 months
BMI according growth charts
average of 3 months
Fat mass
大体时间:average of 3 months
Fat mass by impedance bioeletrical
average of 3 months
Fat free mass
大体时间:average of 3 months
fat free mass by impedance bioeletrical
average of 3 months
Phase angle
大体时间:average of 3 months
phase angle mass by impedance bioeletrical
average of 3 months

其他结果措施

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Mariana Baldini Prudencio, Master、Universidade of Sao Paulo

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年6月1日

初级完成 (预期的)

2020年7月1日

研究完成 (预期的)

2020年7月1日

研究注册日期

首次提交

2015年10月13日

首先提交符合 QC 标准的

2015年12月28日

首次发布 (估计)

2015年12月31日

研究记录更新

最后更新发布 (估计)

2015年12月31日

上次提交的符合 QC 标准的更新

2015年12月28日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

ketogenic diet的临床试验

3
订阅