Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children

Cognitive Change Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05476549
• Other study ID #: 48CD1
• Status: Completed
• Phase: N/A
• Start date: August 4, 2022
• Est. completion date: August 27, 2023

Study information

• Verified date: December 2023
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 27, 2023
• Est. primary completion date: August 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Behavior, Child
• Cognitive Change

Intervention

Dietary Supplement:
• Lemon verbena
Lemon verbena supplement administered at an estimated daily dose of 15mg/kg
• Placebo
Placebo supplement containing carrier material only

Locations

Country	Name	City	State
United Kingdom	Brain, Performance, Nutrition Research Centre, Northumbria University	Newcastle upon Tyne	Tyne & Wear

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Finzelberg GmbH

Country where clinical trial is conducted

United Kingdom, 

Outcome

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