Effects of Polyphenolic Extract From Pine Bark on the Inattention and Hyperactivity in Patients With Attention Deficit Hyperactivity Disorder Based on the Antioxidative Status.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) or Individual Subjective Perception Job Stress Scale (ISPJSS)
研究概览
简要总结
In this study, the investigators will investigate the effects of polyphenolic extract from pine bark on the inattention and hyperactivity in patients with attention deficit hyperactivity disorder (ADHD) based on antioxidative status.
详细描述
Attention deficit hyperactivity disorder (ADHD) is a disorder characterized by developmentally inappropriate levels of impulsive behavior, hyperactivity and/or inattention. It is one of the most prevalent chronic pediatric neurodevelopmental conditions. The pathology of ADHD may relate to the oxidative stress caused by abnormal neurotransmitters. Therefore, we would like to intervene pine bark extract (PE) which can improve the symptom of inattention and hyperactivity from the psychological assessment and antioxidative status.
20 children and adolescent aged above 7 but under 20 years old and 20 adults aged from 20 to 65 years old with ADHD will be enrolled in this randomized, double-blind, cross-over and placebo controlled 10-weeks period experiment.
At the treatment period (0th to 4th week of the experiment), children and adolescent with ADHD will receive 1~2 placebo or capsules of polyphenolic extract from pine bark (25mg Oligopin per capsule) according to their body weight. On the other hand, adult with ADHD will receive 2~3 placebo or capsules of polyphenolic extract from pine bark (50mg Oligopin per capsule). The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment. Psychiatric examination and nutrition status evaluation will be carried out in this study. At the beginning, 4th, 7th and 10th week of the study, basic psychiatric examination will be carried out by clinical psychologist. Routine laboratory parameter including liver function, kidney function, lipid profile, antioxidative status and iron status will be investigated at the beginning, 4th and 10th week of the study. The nutrition status evaluation including food frequency questionnaire and three-day dietary record (two days on weekdays, one day on holiday). The food frequency questionnaire will be performed at the beginning, 4th, 7th and 10th of the experiment while three-day dietary record will be performed at 2th, 4th , 8th and 10th of the experiment. We expect that polyphenolic extract from pine bark may improve oxidative status which in turn ameliorate the attention and emotional stability in patients with ADHD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children or adolescent with attention deficit hyperactivity disorder (ADHD) whose age reach 7 but under 20 and were not treated with ADHD drugs, antihypertensive drugs and dietary supplements more than 4 weeks.
- •Adults with attention deficit hyperactivity disorder (ADHD) aged from 20 to 65 and were not treated with antihypertensive drugs and dietary supplements more than 4 weeks.
排除标准
- •Children or adolescent treated with ADHD drugs, antihypertensive drugs and dietary supplements
- •Adults treated with antihypertensive drugs and dietary supplements
- •Nervous system diseases (including brain or other central nervous system diseases, e.g. epilepsy)
- •Autism spectrum disorder
- •Intellectual disability
- •Other mental disorders (e.g. Schizophrenia, Bipolar Disorder, Major depressive disorder, Anxiety Disorder, Personality disorders, Conduct disorder, Tourette Syndrome.)
- •Hepatic, renal, gastrointestinal and cardiovascular disorders
- •Biochemical abnormality
研究组 & 干预措施
Oligopin®
Dietary supplement, Polyphenolic extract from pine bark. This group receives a nutritional supplement for a period of 10 weeks.
Children and adolescent 20-50 kg body weight: 25 mg Oligopin®/day; > 50 kg body weight: 50 mg Oligopin®/day Adults 40-60 kg body weight: 100 mg Oligopin®/day; > 60 kg body weight: 150 mg Oligopin®/day
干预措施: Oligopin® (Dietary Supplement)
Placebo
Placebo treatment ( identical capsules containing maltodextrin and magnesium stearate )
干预措施: Placebo (Other)
结局指标
主要结局
Adult ADHD Self-Report Scale-V1.1 (ASRS-V1.1) or Individual Subjective Perception Job Stress Scale (ISPJSS)
时间窗: at the start of the experiment and at the 4th, 7th and 10th week
It is used to evaluate the inattention, impulsivity and hyperactivity for adult with ADHD as rated by participants. The scores of ASRS-V1.1 more than 17, that can be going to the next steps. When subjects took Oligopin that scores decrease significantly than beseline on impulsivity and hyperactivity.
Wechsler Memory Scale , WMS-III
时间窗: at the start of the experiment and at the 4th, 7th and 10th week
Use Wechsler memory test to evaluate performance progressing in concentration and impulse control for adults Among the result of WMS, there were no significant difference in each period.
Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV)
时间窗: at the start of the experiment and at the 4th, 7th and 10th week
It is used to evaluate the inattention, impulsivity and hyperactivity for children and adolescent with ADHD as rated by parents and teachers. When Inattention/Hyperactivity-impulsivity subscales approach P85, the participants are going to the next steps. When subjects took Oligopin that scores decrease significantly than beseline on inattention.
Conners' Continuous Performance Test (CPT-III)
时间窗: at the start of the experiment and at the 4th, 7th and 10th week
It is used to evaluate the inattention, impulsivity and vigilance for subjects with ADHD. T-score \> 60 approach clinical standard. In the part of inattention, during supplementation of PE all sub-items were no difference when compared with baseline and sub-items of commissions were lower than placebo group (p\<0.05). Hyperactivity results were the same with part of inattention.
Wisconsin Card Sorting Test, WCST
时间窗: at the start of the experiment and at the 4th, 7th and 10th week
Use Wisconsin card test to evaluate performance progressing in concentration, impulse control for adults Among the results of WCST, there were no significantly difference between each group.
次要结局
- Liver function(at the start of the experiment and at the 4th, 10th week)
- Lipid profile(at the start of the experiment and at the 4th, 10th week)
- Hematology(at the start of the experiment and at the 4th, 10th week)
- Food frequency questionnaire(at the beginning, 4th, 7th and 10th of the experiment)
- Three-day dietary record.(at 2nd , 4th, 6th and 10th week of study)
- Kidney function(at the start of the experiment and at the 4th, 10th week)
- Iron status(at the start of the experiment and at the 4th, 10th week)
- Antioxidative status(at the start of the experiment and at the 4th, 10th week)