Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children
NCT ID: NCT05476549
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
140 participants
INTERVENTIONAL
2022-08-04
2023-08-27
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
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Lemon verbena
Lemon verbena
Lemon verbena supplement administered at an estimated daily dose of 15mg/kg
Placebo
Placebo
Placebo supplement containing carrier material only
Interventions
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Lemon verbena
Lemon verbena supplement administered at an estimated daily dose of 15mg/kg
Placebo
Placebo supplement containing carrier material only
Eligibility Criteria
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Inclusion Criteria
* 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)
8 Years
17 Years
ALL
Yes
Sponsors
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Finzelberg GmbH
INDUSTRY
Northumbria University
OTHER
Responsible Party
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Principal Investigators
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Philippa Jackson, PhD
Role: PRINCIPAL_INVESTIGATOR
Northumbria University
Locations
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Brain, Performance, Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, Tyne & Wear, United Kingdom
Countries
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Other Identifiers
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48CD1
Identifier Type: -
Identifier Source: org_study_id