Behavior, ChildNCT05476549
Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children
A study testing Lemon verbena in people with Behavior, Child and Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 8 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Behavior, Child, Cognitive Change
- What is being tested?
- Lemon verbena
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Aug 2022to 27 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 18Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance, Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST
About this study
Official title: Effects of Lemon Verbena Extract Supplementation on Behaviour Mood and Cognitive Function in Sub-ADHD Children
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
- Being tested
- Lemon verbena, Placebo
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lemon verbenaDietary supplement
Lemon verbena supplement administered at an estimated daily dose of 15mg/kg
PlaceboDietary supplement
Placebo supplement containing carrier material only
| Study group | Role | What they receive |
|---|---|---|
| Lemon verbena | Experimental | Not described Receives: Dietary Supplement: Lemon verbena |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Conners 3 score from baseline to 8 weeks, parent rating
Measured: Baseline to 8 weeks
Change in Conners 3 score from baseline to 8 weeks, child rating
Measured: Baseline to 8 weeks
Change in total mood disturbance from baseline to 8 weeks
Profile of mood states questionnaire
Measured: Baseline to 8 weeks
Change in depression-dejection from baseline to 8 weeks
Profile of mood states questionnaire
Measured: Baseline to 8 weeks
Change in tension-anxiety from baseline to 8 weeks
Profile of mood states questionnaire
Measured: Baseline to 8 weeks
Change in anger-hostility from baseline to 8 weeks
Profile of mood states questionnaire
Measured: Baseline to 8 weeks
Change in confusion-bewilderment from baseline to 8 weeks
Profile of mood states questionnaire
Measured: Baseline to 8 weeks
Change in vigour-activity from baseline to 8 weeks
Profile of mood states questionnaire
Measured: Baseline to 8 weeks
Change in fatigue-inertia from baseline to 8 weeks
Profile of mood states questionnaire
Measured: Baseline to 8 weeks
Change in systolic blood pressure from baseline to 8 weeks
Systolic blood pressure (mmHg)
Measured: Baseline to 8 weeks
Change in diastolic blood pressure from baseline to 8 weeks
Diastolic blood pressure (mmHg)
Measured: Baseline to 8 weeks
Change in body temperature from baseline to 8 weeks
Degrees Celsius
Measured: 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)
Measured: Baseline to 8 weeks
Change in heart rate during the performance of cognitive tasks from baseline to 8 weeks
Beats per minute
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline to 8 weeks
Change in subjective anxiety from baseline to 8 weeks
State-trait anxiety inventory (STAI) total score
Measured: Baseline to 8 weeks
Change in subjective perceived stress from baseline to 8 weeks
Perceived stress scale (PSS) total score
Measured: Baseline to 8 weeks
Change in subjective mood from baseline to 8 weeks, alertness
Visual analogue scale composite score
Measured: Baseline to 8 weeks
Change in subjective mood from baseline to 8 weeks, stress
Visual analogue scale composite score
Measured: Baseline to 8 weeks
Change in subjective mood from baseline to 8 weeks, tranquility
Visual analogue scale composite score
Measured: Baseline to 8 weeks
Change in speed of performance from baseline to 8 weeks
Cognitive task composite score, milliseconds
Measured: Baseline to 8 weeks
Change in accuracy of performance from baseline to 8 weeks
Cognitive task composite score, %
Measured: Baseline to 8 weeks
Change in accuracy of performance on arrow flankers task from baseline to 8 weeks
Cognitive task score, %
Measured: Baseline to 8 weeks
Change in accuracy of performance on numeric working memory task from baseline to 8 weeks
Cognitive task score, %
Measured: Baseline to 8 weeks
Change in accuracy of performance on Stroop task from baseline to 8 weeks
Cognitive task score, %
Measured: Baseline to 8 weeks
Change in accuracy of performance on Corsi blocks task from baseline to 8 weeks
Cognitive task score, %
Measured: Baseline to 8 weeks
Change in accuracy of performance on rapid visual information processing task from baseline to 8 weeks
Cognitive task score, %
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to 8 weeks
Change in completion time of peg and ball task from baseline to 8 weeks
Cognitive task score, time in milliseconds
Measured: Baseline to 8 weeks
Change in thinking time of peg and ball task from baseline to 8 weeks
Cognitive task score, time in milliseconds
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start4 Aug 2022
- Primary completion27 Aug 2023
- Study completion27 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavior, ChildStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Finzelberg GmbH
- Responsible party
- Sponsor
- Investigators
- Philippa Jackson, PhD, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476549
- Sponsor's protocol ID
- 48CD1
- Status last verified
- Dec 2023
- First submitted
- 25 Jul 2022
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lemon Verbena Extract Supplementation on Behaviour Mood and Cognitive Function in Sub-ADHD Children
- ClinicalTrials.gov ID
- NCT05476549
- Acronym / sponsor ID
- 48CD1
- Conditions
- Behavior, Child, Cognitive Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Finzelberg GmbH
- Study start
- 4 Aug 2022 (actual)
- Primary completion
- 27 Aug 2023 (actual)
- Study completion
- 27 Aug 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lemon verbena | Experimental | Dietary Supplement: Lemon verbena |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lemon verbenaLemon verbena supplement administered at an estimated daily dose of 15mg/kg | Dietary supplement | Lemon verbena |
| PlaceboPlacebo supplement containing carrier material only | Dietary supplement | Placebo |
Primary outcome
Change in Conners 3 score from baseline to 8 weeks, parent rating
Time frame: Baseline to 8 weeks
Change in Conners 3 score from baseline to 8 weeks, child rating
Time frame: Baseline to 8 weeks
Change in total mood disturbance from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Profile of mood states questionnaire
Change in depression-dejection from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Profile of mood states questionnaire
Change in tension-anxiety from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Profile of mood states questionnaire
Change in anger-hostility from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Profile of mood states questionnaire
Change in confusion-bewilderment from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Profile of mood states questionnaire
Change in vigour-activity from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Profile of mood states questionnaire
Change in fatigue-inertia from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Profile of mood states questionnaire
Change in systolic blood pressure from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Systolic blood pressure (mmHg)
Change in diastolic blood pressure from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Diastolic blood pressure (mmHg)
Change in body temperature from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Degrees Celsius
Change in RMSSD during the performance of cognitive tasks from baseline to 8 weeks
Time frame: 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
Time frame: Baseline to 8 weeks
Beats per minute
Change in heart rate variability index during the performance of cognitive tasks from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Heart rate variability index
Change in pNN50 during the performance of cognitive tasks from baseline to 8 weeks
Time frame: 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
Time frame: 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
Time frame: Baseline to 8 weeks
State-trait anxiety inventory (STAI) total score
Change in subjective perceived stress from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Perceived stress scale (PSS) total score
Change in subjective mood from baseline to 8 weeks, alertness
Time frame: Baseline to 8 weeks
Visual analogue scale composite score
Change in subjective mood from baseline to 8 weeks, stress
Time frame: Baseline to 8 weeks
Visual analogue scale composite score
Change in subjective mood from baseline to 8 weeks, tranquility
Time frame: Baseline to 8 weeks
Visual analogue scale composite score
Change in speed of performance from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Cognitive task composite score, milliseconds
Change in accuracy of performance from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Cognitive task composite score, %
Change in accuracy of performance on arrow flankers task from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Cognitive task score, %
Change in accuracy of performance on numeric working memory task from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Cognitive task score, %
Change in accuracy of performance on Stroop task from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Cognitive task score, %
Change in accuracy of performance on Corsi blocks task from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Cognitive task score, %
Change in accuracy of performance on rapid visual information processing task from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Cognitive task score, %
Change in accuracy of performance on peg and ball task from baseline to 8 weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline to 8 weeks
Cognitive task score, time in milliseconds
Change in thinking time of peg and ball task from baseline to 8 weeks
Time frame: Baseline to 8 weeks
Cognitive task score, time in milliseconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippa Jackson, PhD principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lemon verbena in people with Behavior, Child and Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Conners 3 score from baseline to 8 weeks, parent rating (time frame: Baseline to 8 weeks). The study lists 37 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.