Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children

Northumbria University

Status

Completed

Conditions

Behavior, Child

Cognitive Change

Treatments

Dietary Supplement: Lemon verbena

Dietary Supplement: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05476549

48CD1

Details and patient eligibility

About

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.

Enrollment

140 patients

Sex

All

Ages

8 to 17 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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
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)