22206 cognitive function and behavior in school childre

Not Applicable

Registration Number: CTRI/2023/11/060026

Lead Sponsor: Earths Creation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Closed to Recruitment of Participants

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Healthy school children (boys and girls), between 6 and 12 years, reported as hyperactive and inattentive by their parents or teachers.

2.Subjects with a minimum ADHD-RS-5 total score of greater than or equal to 28 at screening.

3.Subjects who are fluent in English (able to speak, read, and write).

4.Subjects with adequate visual and auditory acuity to allow neuropsychological testing.

5.Parent/legal guardian willing to personally provide informed consent, indicating that they have been informed of all pertinent aspects of the trial.

6.Subjects willing to provide a signed copy of a simplified children’s consent form.

7.Subjects willing to provide a blood sample for laboratory investigations.

8.The Results of screening are within the normal range or considered not clinically significant by the Principal investigator.

Exclusion Criteria

1.Subjects who underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.

2.Subjects diagnosed with Oppositional Defiant Disorder or a similar behavioral disorder.

3.Does not meet the minimum cut-off (Less than 80) on WISC-IV-SF to participate in the trial.

4.Currently taking any medication (including herbal supplements or stimulants as part of treatment for an ADHD diagnosis).

5.Subjects taking vitamins/fish oil supplements for greater than 3 months.

6.History of current heart disease, high blood pressure or diabetes

7.Health conditions that would affect food metabolism, including the following: food allergies, kidney disease, liver disease and/or gastrointestinal diseases (e.g. irritable bowel syndrome, coeliac disease, peptic ulcers).

8.Unable to participate in all scheduled visits, the treatment plan, tests, and other trial procedures according to the protocol.

9.Currently participating or participated in another clinical trial during the last 2 months prior to the beginning of this study.

10.Inability to make decisions regarding study participation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline to days 14, 28, 56 and 84 in: <br/ ><br>Auditory Verbal Learning Test <br/ ><br>Timepoint: Day 1 (baseline), Day 14, Day 28, Day 56 and Day 84

Secondary Outcome Measures

Name	Time	Method
Change from baseline to days 14, 28, 56 and 84 in: Level of inattention and hyperactivity on a Conners Parent Rating Scale short formTimepoint: Day 1 (baseline), Day 14, Day 28, Day 56 and Day 84;Children’s Sleep Habits QuestionnaireTimepoint: Day 1 (baseline), Day 14, Day 28, Day 56 and Day 84;Reaction time (RT) in a simple response time task for a PEBL batteryTimepoint: Day 1 (baseline), Day 14, Day 28, Day 56 and Day 84;Scores from the Tower of London testTimepoint: Day 1 (baseline), Day 14, Day 28, Day 56 and Day 84;Scores of a Stroop color and a word test in the PEBL BatteryTimepoint: Day 1 (baseline), Day 14, Day 28, Day 56 and Day 84;Scores of Match-To Sample (MTS) taskTimepoint: Day 1 (baseline), Day 14, Day 28, Day 56 and Day 84