Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lemon verbena
|
Dietary Supplement: Lemon verbena
Lemon verbena supplement administered at an estimated daily dose of 15mg/kg
|
| Placebo Comparator: Placebo
|
Dietary Supplement: Placebo
Placebo supplement containing carrier material only
|
Outcome Measures
Primary Outcome Measures
- 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 numeric working memory 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
Eligibility Criteria
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
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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.
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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
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Do not have a diagnosed neurological condition, or learning/behavioural or neurodevelopmental differences (e.g. dyslexia, autism)
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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).
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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.
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Can complete all of the study assessments at the training visit
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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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brain, Performance, Nutrition Research Centre, Northumbria University | Newcastle upon Tyne | Tyne & Wear | United Kingdom | NE1 8ST |
Sponsors and Collaborators
- Northumbria University
- Finzelberg GmbH
Investigators
- Principal Investigator: Philippa Jackson, PhD, Northumbria University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 48CD1