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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
140
Lemon verbena supplement administered at an estimated daily dose of 15mg/kg
Placebo supplement containing carrier material only
Brain, Performance, Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Change in Conners 3 score from baseline to 8 weeks, parent rating
Time frame: Baseline to 8 weeks
Change in Conners 3 score from baseline to 8 weeks, child rating
Time frame: Baseline to 8 weeks
Change in total mood disturbance from baseline to 8 weeks
Profile of mood states questionnaire
Time frame: Baseline to 8 weeks
Change in depression-dejection from baseline to 8 weeks
Profile of mood states questionnaire
Time frame: Baseline to 8 weeks
Change in tension-anxiety from baseline to 8 weeks
Profile of mood states questionnaire
Time frame: Baseline to 8 weeks
Change in anger-hostility from baseline to 8 weeks
Profile of mood states questionnaire
Time frame: Baseline to 8 weeks
Change in confusion-bewilderment from baseline to 8 weeks
Profile of mood states questionnaire
Time frame: Baseline to 8 weeks
Change in vigour-activity from baseline to 8 weeks
Profile of mood states questionnaire
Time frame: Baseline to 8 weeks
Change in fatigue-inertia from baseline to 8 weeks
Profile of mood states questionnaire
Time frame: Baseline to 8 weeks
Change in systolic blood pressure from baseline to 8 weeks
Systolic blood pressure (mmHg)
Time frame: Baseline to 8 weeks
Change in diastolic blood pressure from baseline to 8 weeks
Diastolic blood pressure (mmHg)
Time frame: Baseline to 8 weeks
Change in body temperature from baseline to 8 weeks
Degrees Celsius
Time frame: Baseline to 8 weeks
Change in RMSSD during the performance of cognitive tasks from baseline to 8 weeks
Root mean square of successive differences between normal heartbeats (RMSSD)
Time frame: Baseline to 8 weeks
Change in heart rate during the performance of cognitive tasks from baseline to 8 weeks
Beats per minute
Time frame: Baseline to 8 weeks
Change in heart rate variability index during the performance of cognitive tasks from baseline to 8 weeks
Heart rate variability index
Time frame: Baseline to 8 weeks
Change in pNN50 during the performance of cognitive tasks from 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.
Time frame: Baseline to 8 weeks
Change in stress index during the performance of cognitive tasks from baseline to 8 weeks
The stress index is a measure of the ratio between the parasympathetic and sympathetic tone. intervals exceeds 50 milliseconds.
Time frame: Baseline to 8 weeks
Change in subjective anxiety from baseline to 8 weeks
State-trait anxiety inventory (STAI) total score
Time frame: Baseline to 8 weeks
Change in subjective perceived stress from baseline to 8 weeks
Perceived stress scale (PSS) total score
Time frame: Baseline to 8 weeks
Change in subjective mood from baseline to 8 weeks, alertness
Visual analogue scale composite score
Time frame: Baseline to 8 weeks
Change in subjective mood from baseline to 8 weeks, stress
Visual analogue scale composite score
Time frame: Baseline to 8 weeks
Change in subjective mood from baseline to 8 weeks, tranquility
Visual analogue scale composite score
Time frame: Baseline to 8 weeks
Change in speed of performance from baseline to 8 weeks
Cognitive task composite score, milliseconds
Time frame: Baseline to 8 weeks
Change in accuracy of performance from baseline to 8 weeks
Cognitive task composite score, %
Time frame: Baseline to 8 weeks
Change in accuracy of performance on arrow flankers task from baseline to 8 weeks
Cognitive task score, %
Time frame: Baseline to 8 weeks
Change in accuracy of performance on numeric working memory task from baseline to 8 weeks
Cognitive task score, %
Time frame: Baseline to 8 weeks
Change in accuracy of performance on Stroop task from baseline to 8 weeks
Cognitive task score, %
Time frame: Baseline to 8 weeks
Change in accuracy of performance on Corsi blocks task from baseline to 8 weeks
Cognitive task score, %
Time frame: Baseline to 8 weeks
Change in accuracy of performance on rapid visual information processing task from baseline to 8 weeks
Cognitive task score, %
Time frame: Baseline to 8 weeks
Change in accuracy of performance on peg and ball task from baseline to 8 weeks
Cognitive task score, number of errors
Time frame: Baseline to 8 weeks
Change in reaction time of performance on arrow flankers task from baseline to 8 weeks
Cognitive task score, reaction time in milliseconds
Time frame: Baseline to 8 weeks
Change in reaction time of performance on numeric working memory task from baseline to 8 weeks
Cognitive task score, reaction time in milliseconds
Time frame: Baseline to 8 weeks
Change in reaction time of performance on Stroop task from baseline to 8 weeks
Cognitive task score, reaction time in milliseconds
Time frame: Baseline to 8 weeks
Change in reaction time of performance on rapid visual information processing task from baseline to 8 weeks
Cognitive task score, reaction time in milliseconds
Time frame: Baseline to 8 weeks
Change in false alarms on rapid visual information processing task from baseline to 8 weeks
Cognitive task score, number of false alarms
Time frame: Baseline to 8 weeks
Change in completion time of peg and ball task from baseline to 8 weeks
Cognitive task score, time in milliseconds
Time frame: Baseline to 8 weeks
Change in thinking time of peg and ball task from baseline to 8 weeks
Cognitive task score, time in milliseconds
Time frame: Baseline to 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.