Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Lemon Verbena Extract Supplementation on Behaviour Mood and Cognitive Function in Sub-ADHD Children

Conditions
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Behavior, Child, Cognitive Change

Intervention / Treatment
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* Dietary Supplement: Lemon verbena
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lemon verbena<br> | Dietary Supplement: Lemon verbena<br>* Lemon verbena supplement administered at an estimated daily dose of 15mg/kg<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo supplement containing carrier material only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Conners 3 score from baseline to 8 weeks, parent rating |  | Baseline to 8 weeks | 
| Change in Conners 3 score from baseline to 8 weeks, child rating |  | Baseline to 8 weeks | 
| Change in total mood disturbance from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks | 
| Change in depression-dejection from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks | 
| Change in tension-anxiety from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks | 
| Change in anger-hostility from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks | 
| Change in confusion-bewilderment from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks | 
| Change in vigour-activity from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks | 
| Change in fatigue-inertia from baseline to 8 weeks | Profile of mood states questionnaire | Baseline to 8 weeks | 
| Change in systolic blood pressure from baseline to 8 weeks | Systolic blood pressure (mmHg) | Baseline to 8 weeks | 
| Change in diastolic blood pressure from baseline to 8 weeks | Diastolic blood pressure (mmHg) | Baseline to 8 weeks | 
| Change in body temperature from baseline to 8 weeks | Degrees Celsius | 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) | Baseline to 8 weeks | 
| Change in heart rate during the performance of cognitive tasks from baseline to 8 weeks | Beats per minute | 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 | 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. | 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. | Baseline to 8 weeks | 
| Change in subjective anxiety from baseline to 8 weeks | State-trait anxiety inventory (STAI) total score | Baseline to 8 weeks | 
| Change in subjective perceived stress from baseline to 8 weeks | Perceived stress scale (PSS) total score | Baseline to 8 weeks | 
| Change in subjective mood from baseline to 8 weeks, alertness | Visual analogue scale composite score | Baseline to 8 weeks | 
| Change in subjective mood from baseline to 8 weeks, stress | Visual analogue scale composite score | Baseline to 8 weeks | 
| Change in subjective mood from baseline to 8 weeks, tranquility | Visual analogue scale composite score | Baseline to 8 weeks | 
| Change in speed of performance from baseline to 8 weeks | Cognitive task composite score, milliseconds | Baseline to 8 weeks | 
| Change in accuracy of performance from baseline to 8 weeks | Cognitive task composite score, % | Baseline to 8 weeks | 
| Change in accuracy of performance on arrow flankers task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks | 
| Change in accuracy of performance on numeric working memory task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks | 
| Change in accuracy of performance on Stroop task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks | 
| Change in accuracy of performance on Corsi blocks task from baseline to 8 weeks | Cognitive task score, % | Baseline to 8 weeks | 
| Change in accuracy of performance on rapid visual information processing task from baseline to 8 weeks | Cognitive task score, % | 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 | 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 | 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 | 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 | 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 | 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 | Baseline to 8 weeks | 
| Change in completion time of peg and ball task from baseline to 8 weeks | Cognitive task score, time in milliseconds | Baseline to 8 weeks | 
| Change in thinking time of peg and ball task from baseline to 8 weeks | Cognitive task score, time in milliseconds | Baseline to 8 weeks |