Behavior, Child, Cognitive Change
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTLemon verbena
Lemon verbena supplement administered at an estimated daily dose of 15mg/kg
DIETARY_SUPPLEMENTPlacebo
Placebo supplement containing carrier material only
Sponsors
Finzelberg GmbH
Northumbria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in reaction time of performance on numeric working memory task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, reaction time in milliseconds |
| 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 | Baseline to 8 weeks | Profile of mood states questionnaire |
| Change in depression-dejection from baseline to 8 weeks | Baseline to 8 weeks | Profile of mood states questionnaire |
| Change in tension-anxiety from baseline to 8 weeks | Baseline to 8 weeks | Profile of mood states questionnaire |
| Change in anger-hostility from baseline to 8 weeks | Baseline to 8 weeks | Profile of mood states questionnaire |
| Change in confusion-bewilderment from baseline to 8 weeks | Baseline to 8 weeks | Profile of mood states questionnaire |
| Change in vigour-activity from baseline to 8 weeks | Baseline to 8 weeks | Profile of mood states questionnaire |
| Change in fatigue-inertia from baseline to 8 weeks | Baseline to 8 weeks | Profile of mood states questionnaire |
| Change in systolic blood pressure from baseline to 8 weeks | Baseline to 8 weeks | Systolic blood pressure (mmHg) |
| Change in diastolic blood pressure from baseline to 8 weeks | Baseline to 8 weeks | Diastolic blood pressure (mmHg) |
| Change in body temperature from baseline to 8 weeks | Baseline to 8 weeks | Degrees Celsius |
| Change in RMSSD during the performance of cognitive tasks from baseline to 8 weeks | Baseline to 8 weeks | Root mean square of successive differences between normal heartbeats (RMSSD) |
| Change in heart rate during the performance of cognitive tasks from baseline to 8 weeks | Baseline to 8 weeks | Beats per minute |
| Change in heart rate variability index during the performance of cognitive tasks from baseline to 8 weeks | Baseline to 8 weeks | Heart rate variability index |
| Change in pNN50 during the performance of cognitive tasks from baseline to 8 weeks | 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 stress index during the performance of cognitive tasks from baseline to 8 weeks | 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 anxiety from baseline to 8 weeks | Baseline to 8 weeks | State-trait anxiety inventory (STAI) total score |
| Change in subjective perceived stress from baseline to 8 weeks | Baseline to 8 weeks | Perceived stress scale (PSS) total score |
| Change in subjective mood from baseline to 8 weeks, alertness | Baseline to 8 weeks | Visual analogue scale composite score |
| Change in subjective mood from baseline to 8 weeks, stress | Baseline to 8 weeks | Visual analogue scale composite score |
| Change in subjective mood from baseline to 8 weeks, tranquility | Baseline to 8 weeks | Visual analogue scale composite score |
| Change in speed of performance from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task composite score, milliseconds |
| Change in accuracy of performance from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task composite score, % |
| Change in accuracy of performance on arrow flankers task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, % |
| Change in accuracy of performance on numeric working memory task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, % |
| Change in accuracy of performance on Stroop task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, % |
| Change in accuracy of performance on Corsi blocks task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, % |
| Change in accuracy of performance on rapid visual information processing task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, % |
| Change in accuracy of performance on peg and ball task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, number of errors |
| Change in reaction time of performance on arrow flankers task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, reaction time in milliseconds |
| Change in reaction time of performance on Stroop task from baseline to 8 weeks | 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 | Baseline to 8 weeks | Cognitive task score, reaction time in milliseconds |
| Change in false alarms on rapid visual information processing task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, number of false alarms |
| Change in completion time of peg and ball task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, time in milliseconds |
| Change in thinking time of peg and ball task from baseline to 8 weeks | Baseline to 8 weeks | Cognitive task score, time in milliseconds |
Countries
United Kingdom
Outcome results
None listed