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
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
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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SP
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Sao Paulo、SP、巴西、01246-904
- 招聘中
- Nagila Raquel Teixeira Damasceno
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接触:
- Patricia Azevedo, PhD Student
- 电话号码:1130617865
- 邮箱:patricia.azlima@yahoo.com.br
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
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 .
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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 .
学习计划
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 |
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有源比较器:Group control
classical ketogenic diet
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Ketogenic diet with high fat (90%)
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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
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Ketogenic diet with high fat (90%)
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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
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age, income, disease, parent´s education, use of drugs and supplements, type of seizures, questions about quality of life
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average of 3 months
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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
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BMI according growth charts
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average of 3 months
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Fat mass
大体时间:average of 3 months
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Fat mass by impedance bioeletrical
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average of 3 months
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Fat free mass
大体时间:average of 3 months
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fat free mass by impedance bioeletrical
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average of 3 months
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Phase angle
大体时间:average of 3 months
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phase angle mass by impedance bioeletrical
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average of 3 months
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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
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Food record applied during 3 days to each time
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average of 3 months
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Ketone bodies
大体时间:average of 3 months
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Concentration of B-hydroxybutirate in plasma.
Determination with kit Ranbut (Randox Laboratories Limited, Reino Unido).
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average of 3 months
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Lipid profile
大体时间:average of 3 months
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Total cholesterol, LDL, HDL, TG
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average of 3 months
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NEFAS
大体时间:average of 3 months
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Concentration in plasma.
Determination with kit NEFAS(Randox Laboratories Limited, Reino Unido)
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average of 3 months
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LDL oxidized
大体时间:average of 3 months
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Determination in plasma
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average of 3 months
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Antioxidant
大体时间:average of 3 months
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Determination of antioxidant concentration in plasma by HPLC
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average of 3 months
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Metabolomic (lipidomic)
大体时间:average of 3 months
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Determination in plasma by mass spectrometry
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average of 3 months
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Subfractions of Lipoproteins
大体时间:average of 3 months
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Determination in plasma by Lipoprint
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average of 3 months
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Liver enzymes
大体时间:average of 3 months
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Concentration of AST, ALT, GGT
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average of 3 months
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Hepatic function
大体时间:average of 3 months
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Ultrasound liver
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average of 3 months
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Leptin
大体时间:average of 3 months
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Determination in plasma
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average of 3 months
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Resistin
大体时间:average of 3 months
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Determination in plasma
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average of 3 months
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合作者和调查者
调查人员
- 学习椅:Mariana Baldini Prudencio, Master、Universidade of Sao Paulo
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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ketogenic diet的临床试验
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Rush University Medical CenterUniversity of Chicago; National Institute on Aging (NIA); Advocate Hospital System招聘中
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University of CalgaryStewart Diabetes Education Fund完全的