Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 主要终点
- Changes Related Potential Recording after 3 months of dietary approach
研究概览
简要总结
Multicenter, Prospective, randomized, comparative and controlled study about the beneficial effects in behavior and brain connectivity of different dietary patterns in 100 children with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.
详细描述
We collect electroencephalogram (EEG), event related potentials (ERP) data, and behavior parameters in ADD/ADHD children that not take stimulants or other drugs during study. They would only follow some nutritional recommendations based on increasing the amount of dietary protein and fast carbohydrates decrease. The duration of the study will be 6 months, 3 months for recruitment and 3 months for dietary treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 7 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ADHD diagnosed 12 months before
- •no take medication
- •BMI above the 25th percentile
- •Wiesel score between 80 and 100 (about 120)
- •Patients who agree to participate and whose guardians signed the informed consent form
排除标准
- •eating disorders
- •psychosis, bipolar disorder or depression
- •kidney or liver failure
- •diuretic or cortisone treatment
- •haematological problems
- •suprarenal diseases
- •Brain injury
- •Cardiovascular or arrhythmia problems
研究组 & 干预措施
BP22042013
This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
干预措施: BP22042013 (Drug)
Low carbohydrate Diet
the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements
干预措施: Low carbohydrate diet (Dietary Supplement)
结局指标
主要结局
Changes Related Potential Recording after 3 months of dietary approach
时间窗: 3 months
Evaluate changes in reaction time, omission and comission errors, latencies and amplitudes in brainwaves during visual continuous performance task from 19 channels EEG recordings, before begin nutritional measures and after 3 months of dietary approach.
次要结局
- Quantitative Electroencephalogram(3 months)
- Behavior(3 months)