Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children

NCT05476549 | Completed

• 1 other identifier: 48CD1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Behavior, Child; Cognitive Change

Outcome Measures

Primary Outcomes (37)

• 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

Study Arms (2)

Lemon verbena

EXPERIMENTAL

Dietary Supplement: Lemon verbena

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Lemon verbena DIETARY_SUPPLEMENT

Lemon verbena supplement administered at an estimated daily dose of 15mg/kg

Lemon verbena

Placebo DIETARY_SUPPLEMENT

Placebo supplement containing carrier material only

Placebo

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• Finzelberg GmbH: collaborator

Study Sites (1)

Brain, Performance, Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Location

MeSH Terms

Conditions

Child Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Philippa Jackson, PhD

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 27, 2022
• Study Start: August 4, 2022
• Primary Completion: August 27, 2023
• Study Completion: August 27, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Locations

GB (1)