Clinical trial NCT05476549: Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children
Official title: Effects of Lemon Verbena Extract Supplementation on Behaviour Mood and Cognitive Function in Sub-ADHD Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior, Child
Cognitive Change
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: Finzelberg GmbH
First posted: 2022-07-27
Enrollment: 140
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Change in Conners 3 score from baseline to 8 weeks, parent rating
timeFrame: Baseline to 8 weeks
measure: Change in Conners 3 score from baseline to 8 weeks, child rating
timeFrame: Baseline to 8 weeks
measure: Change in total mood disturbance from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in depression-dejection from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in tension-anxiety from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in anger-hostility from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in confusion-bewilderment from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in vigour-activity from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in fatigue-inertia from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in systolic blood pressure from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in diastolic blood pressure from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in body temperature from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in RMSSD during the performance of cognitive tasks from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in heart rate during the performance of cognitive tasks from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in heart rate variability index during the performance of cognitive tasks from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in pNN50 during the performance of cognitive tasks from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in stress index during the performance of cognitive tasks from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in subjective anxiety from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in subjective perceived stress from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in subjective mood from baseline to 8 weeks, alertness
timeFrame: Baseline to 8 weeks
measure: Change in subjective mood from baseline to 8 weeks, stress
timeFrame: Baseline to 8 weeks
measure: Change in subjective mood from baseline to 8 weeks, tranquility
timeFrame: Baseline to 8 weeks
measure: Change in speed of performance from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in accuracy of performance from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in accuracy of performance on arrow flankers task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in accuracy of performance on numeric working memory task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in accuracy of performance on Stroop task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in accuracy of performance on Corsi blocks task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in accuracy of performance on rapid visual information processing task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in accuracy of performance on peg and ball task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in reaction time of performance on arrow flankers task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in reaction time of performance on numeric working memory task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in reaction time of performance on Stroop task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in reaction time of performance on rapid visual information processing task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in false alarms on rapid visual information processing task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in completion time of peg and ball task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
measure: Change in thinking time of peg and ball task from baseline to 8 weeks
timeFrame: Baseline to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Brain, Performance, Nutrition Research Centre, Northumbria University
state: Tyne & Wear
Study officials:
affiliation: Northumbria University
name: Philippa Jackson, PhD
role: PRINCIPAL_INVESTIGATOR
References: