Clinical trial NCT05177978: The Cognitive Effects of 6- and 12-weeks Administration of a Food Supplement Containing Phosphatidylserine in Healthy Children Aged 8 to 12 Years
Official title: The Chronic Cognitive Effects of 6- and 12-weeks Administration of a Food Supplement Containing Phosphatidylserine: A Double Blind, Randomized, Placebo Controlled, Parallel Groups Study in Healthy Children Aged 8 to 12 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Keywords: Cognition
Phosphatidylserine
Memory
Learning
Attention
Lead sponsor: Northumbria University
Sponsor class: OTHER
Collaborators: name: International Flavors & Fragrances Inc.
First posted: 2022-01-05
Enrollment: 208
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the cognitive effects (attention, learning, and memory) of 6 and 12 weeks administration of a supplement containing phosphatidylserine in comparison to a placebo in healthy children aged 8 to 12 years old. The study will utilize Rey Auditory Verbal Learning Test (RAVLT) and Computerised Mental Performance Assessment System (COMPASS, Northumbria University) for a broad assessment of cognitive function/learning, and actigraphy to monitor sleep.


Eligibility criteria: Inclusion Criteria:

* Participants must be in good health as reported by themselves and their parent/guardian.
* Healthy children aged 8 to 12 years and enrolled in school years 4 to 7 at the time of giving consent
* Have been speaking English at school since reception
* Willingness of the children and parents to give their written informed consent, according to GCP and local regulations and being able to participate in all scheduled visits, intervention plans, tests and other trial procedures
* Children with a normal sex and age-related BMI according to the local NHS guidelines (3rd to 90th percentiles)

Exclusion Criteria:

* Relevant allergy or known hypersensitivity to one of the ingredients contained in the investigational drug.
* Are currently taking any illicit, herbal or recreational drugs including alcohol and tobacco.
* Taking any prescribed or OTC medication against chronic or non- chronic illnesses.
* Have used dietary supplements within the last 4 weeks
* Are diagnosed with ADHD, dyslexia or any neurodevelopmental disorder or learning difficulty.
* Suffer from visual (including colour blindness) or hearing impairment (that may impact task performance in the opinion of the PI.
* Have any serious illness, cognitive impairment or medical disorder that may confound with study results or interfere with compliance.
* Have any other active or unstable medical condition, that, in the opinion of the PI, may adversely affect the participant's ability to complete the study
* Are experiencing exceptional social/family stressors.
* Consume more than one portion (\>100g) per week of the following dietary sources high in phosphatidylserine: Oily fish such as salmon, mackerel, herring, tuna and eel. Animal internal organs such as liver, kidney, brain and heart. Note: Information on continued adherence to this criteria will be captured within treatment diary. If a child continuously consumes more than one portion per week of PS rich food the sponsor will be informed on a case by case basis. If deemed to be significant, they will be excluded, (but allowed to continue the study to the end (day 84)) and will be replaced.
* Subjects that have followed specific diet, e.g. high protein diet, within 30 days prior to study start
* Serious diet change, e.g. Ketogenic or vegan, within 30 days prior to study start.
* Consumption of \> 250 mg/day of caffeine.
* Are unable to complete all of the study assessments
* Are currently participating in other clinical or nutrition intervention studies, or have in the past 8 weeks
* Are non-compliant with regards treatment consumption

Primary outcomes:
measure: COMPASS global performance measures
timeFrame: Following 12 weeks of intervention
measure: Cognitive domain factor score
timeFrame: Following 12 weeks of intervention
measure: Location Learning score
timeFrame: Following 12 weeks of intervention
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Following 12 weeks of intervention
Secondary outcomes:
measure: COMPASS global performance measures
timeFrame: Following 6 weeks of intervention
measure: Cognitive domain factor score
timeFrame: Following 6 weeks of intervention
measure: Location Learning score
timeFrame: Following 6 weeks of intervention
measure: Rey Auditory Verbal Learning Test (RAVLT)
timeFrame: Following 6 weeks of intervention
measure: Individual cognitive task score
timeFrame: Following 6 and 12 weeks of intervention
measure: Children's Sleep Habits Questionnaire (CSHQ)
timeFrame: Following 6 and 12 weeks of intervention
measure: Children's Sleep self-report (SSR) questionnaire
timeFrame: Following 6 and 12 weeks of intervention
measure: Sleep measures
timeFrame: Following 12 weeks of intervention
measure: Parent Visual Analogue Scales (VAS)
timeFrame: Following 6 and 12 weeks of intervention
measure: Child mood Visual Analogue Scales (VAS)
timeFrame: Following 6 and 12 weeks of intervention
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Brain, Performance, Nutrition Research Centre, Northumbria University
state: Tyne & Wear
Study officials:
affiliation: Northumbria University
name: Philippa Jackson
role: PRINCIPAL_INVESTIGATOR
References: