The Effects of Low Glycemic Index Diet on Epileptic Seizure Frequency, Oxidative Stress, Mental Health, and Health-related Quality of Life in Children With Drug-resistant Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Concentration of Paraoxonase Enzyme Activity
研究概览
简要总结
The goal of this clinical trial was to evaluate the effectiveness of a low glycemic index diet (LGID) on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy. Based upon the aims, the following hypotheses were tested:
- LGID reduces seizure frequency in children with drug-resistant epilepsy.
- LGID improves oxidative parameters in children with drug-resistant epilepsy
- LGID improves quality of life and mental health in children with drug-resistant epilepsy
Participants were prescribed the LGID for 3 months.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements were collected. Diet compliance was evaluated by food consumption records during monthly follow-up visits (at 1 , 2, and 3 months).
详细描述
The aim of this study was to evaluate the efficacy of a low glycemic index diet on seizure frequency, oxidative stress markers and quality of life in children with drug-resistant epilepsy.This study was a prospective, non-randomized, single centre intervention conducted in children with drug-resistant epilepsy. Low glycemic index diet was started on an out-patient basis. Children and their parents were educated about the diet and the effect of the diet on seizures. Children who were willing to follow the diet were included in the study. The research dietitian conducted interviews with patients and their parents at the beginning of the study to explain the principles of the diet.At baseline and at outpatient clinic follow-ups at 3 months, anthropometric measurements were taken, the strengths and difficulties questionnaire (SDQ), Pediatric Inventory of Quality of Life (PedsQL) and depression scales were administered and samples for biochemical measurements including oxidative stress parameters were collected. A 3-day dietary intake chart kept by the parents was reviewed at each monthly visit to check and reinforce compliance. Parents were asked to record the seizure frequency and severity in a seizure diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being between the ages of 4-18,
- •being diagnosed with drug-resistant epilepsy,
- •having more than one seizure per week,
- •not having followed a ketogenic diet before.
- •willing to come for regular follow up
排除标准
- •children with known or suspected congenital metabolic, chronic, and systemic diseases in which ketogenic diet is contraindicated.
- •non-compliance with the diet recommended by the patient and/or parents
- •enteral tube or parenteral feeding
结局指标
主要结局
Concentration of Paraoxonase Enzyme Activity
时间窗: Baseline and Month 3
Measurement of Paraoxonase Enzyme Activity (PON-1)
Changes in seizure frequency
时间窗: Baseline and Month 3
Seizure diary was kept by parents to records seizure frequency and severity
Concentration of antioxidant and oxidant status
时间窗: Baseline and Month 3
Measurement of oxidative stress markers (Total Antioxidant Status (TAS), Total Oxidant Status (TOS))
Changes in quality of life
时间窗: Baseline and Month 3
"Pediatric Inventory of Quality of Life" was applied to assess health-related quality of life. A higher score corresponds to a higher health-related quality of life. The score ranges from 0 to 100
Changes in depression level
时间窗: Baseline and Month 3
Depression status was assessed by the "Children's Depression Scale".Scores that can be obtained from the scale can vary between 0-54. The cut-off point of the depression scale for children is 19, and high scores indicate a high risk of depression.
Concentration of Malondialdehyde (MDA)
时间窗: Baseline and Month 3
Measurement of Malondialdehyde (MDA)
Changes in psychosocial problems
时间窗: Baseline and Month 3
Psychosocial problems were assessed by the "Strengths and Difficulties Questionnaire".The questionnaire includes 25 questions, some of which question positive and some of which question negative behavioral characteristics. These questions are grouped under 5 sub-headings. These are behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems and social behaviors. Each heading is evaluated in itself with scores that range from 0 to 10 and the sum of the first four headings gives the "total difficulty score". While high scores in social behavior reflect the individual's strengths in the social domain, high scores in the other four domains (behavioral problems, attention deficit and hyperactivity, emotional problems, peer problems) reflect that the problem areas are severe.
次要结局
- Concentration of glucose(Baseline and Month 3)
- Changes in lipid profile(Baseline and Month 3)
- Concentration of insulin(Baseline and Month 3)
- Concentration of liver function tests(Baseline and Month 3)
研究者
Gamze Yurtdaş Depboylu
Associate professor
Izmir Katip Celebi University