Effects of Lemon Verbena Extract Supplementation on Behaviour Mood and Cognitive Function in Sub-ADHD Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Change in Conners 3 score from baseline to 8 weeks, parent rating
研究概览
简要总结
The aim of this study is to investigate the effects of 15 mg/kg lemon verbena, in comparison to placebo, on the attention deficit hyperactivity disorder (ADHD) type behaviour and cognitive function of children who do not have a diagnosis of ADHD, but who exhibit high scores (highest tertile) on ADHD behaviour parameters. Multiple aspects of mood will also be assessed.
The proposed randomised, double-blind, placebo-controlled, parallel groups design methodology will assess the psychological effects of 15 mg/kg lemon verbena extract and a matched placebo prior to and after 4 and 8 weeks of supplementation. The trial will utilise the COMPASS cognitive assessment system (Northumbria University) and a range of mood measures during laboratory testing visits.
Parents and children will also take part in a concomitant smartphone study, comprising the collection of the parent's assessment of the child's behaviour/cognitive function and the child's self-report of the same, plus their mood. These assessments will take place on Days -1, 14, 28, 42 and 56.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are in good health as reported by themselves and their parent/guardian
- •Are aged 8 to 17 years at the time of giving assent and parents giving consent
- •Have a sex and age-related BMI less than the 98th centile according to the local NHS guidelines
- •Are rated by their parents as having a high score (T score of ≥60) on both the Connors 3 subscales of Inattention and Hyperactivity/Impulsivity.
- •Have no current diagnosis of ADHD
- •Have no relevant food intolerances/ sensitivities/ allergies
- •Are not currently using any illicit, herbal or recreational drugs including alcohol and nicotine products
- •Are not currently taking prescription medications
- •Have not taken dietary supplements e.g. Vitamins, omega 3 fish oils etc. in the last 4 weeks
- •Do not have a diagnosed neurological condition, or learning/behavioural or neurodevelopmental differences (e.g. dyslexia, autism)
- •Do not suffer from visual (including colour blindness) impairment that cannot be corrected with glasses or lenses (that may impact task performance in the opinion of the PI).
- •Do not have any pre-existing diagnosed medical condition/illness which will impact taking part in the study
- •Consume less than 250 mg/day of caffeine.
- •Can complete all of the study assessments at the training visit
- •Are not currently participating in other clinical or nutrition intervention studies, or have in the past 4 weeks
- •Are compliant with regards to treatment consumption
- •Have not taken antibiotics within the past 4 weeks
- •Do not have any health condition that would prevent fulfilment of the study requirements (this includes non-diagnosed conditions for which no medication may be taken)
排除标准
- 未提供
结局指标
主要结局
Change in Conners 3 score from baseline to 8 weeks, parent rating
时间窗: Baseline to 8 weeks
Change in vigour-activity from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Profile of mood states questionnaire
Change in fatigue-inertia from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Profile of mood states questionnaire
Change in heart rate during the performance of cognitive tasks from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Beats per minute
Change in depression-dejection from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Profile of mood states questionnaire
Change in systolic blood pressure from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Systolic blood pressure (mmHg)
Change in diastolic blood pressure from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Diastolic blood pressure (mmHg)
Change in confusion-bewilderment from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Profile of mood states questionnaire
Change in body temperature from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Degrees Celsius
Change in RMSSD during the performance of cognitive tasks from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Root mean square of successive differences between normal heartbeats (RMSSD)
Change in heart rate variability index during the performance of cognitive tasks from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Heart rate variability index
Change in subjective mood from baseline to 8 weeks, alertness
时间窗: Baseline to 8 weeks
Visual analogue scale composite score
Change in Conners 3 score from baseline to 8 weeks, child rating
时间窗: Baseline to 8 weeks
Change in anger-hostility from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Profile of mood states questionnaire
Change in subjective perceived stress from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Perceived stress scale (PSS) total score
Change in reaction time of performance on arrow flankers task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, reaction time in milliseconds
Change in reaction time of performance on rapid visual information processing task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, reaction time in milliseconds
Change in total mood disturbance from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Profile of mood states questionnaire
Change in tension-anxiety from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Profile of mood states questionnaire
Change in stress index during the performance of cognitive tasks from baseline to 8 weeks
时间窗: Baseline to 8 weeks
The stress index is a measure of the ratio between the parasympathetic and sympathetic tone. intervals exceeds 50 milliseconds.
Change in subjective mood from baseline to 8 weeks, stress
时间窗: Baseline to 8 weeks
Visual analogue scale composite score
Change in accuracy of performance from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task composite score, %
Change in accuracy of performance on arrow flankers task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, %
Change in accuracy of performance on Corsi blocks task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, %
Change in accuracy of performance on rapid visual information processing task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, %
Change in reaction time of performance on Stroop task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, reaction time in milliseconds
Change in pNN50 during the performance of cognitive tasks from baseline to 8 weeks
时间窗: Baseline to 8 weeks
pNN50 is the mean number of times per hour in which the change in consecutive normal sinus (NN) intervals exceeds 50 milliseconds.
Change in subjective anxiety from baseline to 8 weeks
时间窗: Baseline to 8 weeks
State-trait anxiety inventory (STAI) total score
Change in subjective mood from baseline to 8 weeks, tranquility
时间窗: Baseline to 8 weeks
Visual analogue scale composite score
Change in accuracy of performance on Stroop task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, %
Change in reaction time of performance on numeric working memory task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, reaction time in milliseconds
Change in completion time of peg and ball task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, time in milliseconds
Change in speed of performance from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task composite score, milliseconds
Change in accuracy of performance on numeric working memory task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, %
Change in accuracy of performance on peg and ball task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, number of errors
Change in false alarms on rapid visual information processing task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, number of false alarms
Change in thinking time of peg and ball task from baseline to 8 weeks
时间窗: Baseline to 8 weeks
Cognitive task score, time in milliseconds
次要结局
未报告次要终点