MedTrace Logo

Effects of Lemon Verbena Extract Supplementation in Sub-ADHD Children

NCT05476549 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-12-11

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Lemon verbena

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

DIETARY_SUPPLEMENT

Placebo

Placebo supplement containing carrier material only

Sponsors & Collaborators

  • Finzelberg GmbH

    collaborator INDUSTRY

  • Northumbria University

    lead OTHER

Principal Investigators

  • Philippa Jackson, PhD · Northumbria University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2023-08-27
Completion
2023-08-27

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05476549 on ClinicalTrials.gov