The Cognitive Effects of 6- and 12-weeks Administration of a Food Supplement Containing Phosphatidylserine in Healthy Children Aged 8 to 12 Years

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Cognitive Change

Intervention / Treatment
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* Dietary Supplement: Phosphatidylserine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phosphatidylserine<br>100 mg elemental phosphatidylserine | Dietary Supplement: Phosphatidylserine<br>* Phosphatidylserine containing supplement (2 x chewable gummies/day; Total daily dose of 100 mg elemental phosphatidylserine)<br>|
| Placebo Comparator: Placebo<br>Placebo comparator | Dietary Supplement: Placebo<br>* Placebo comparator (2 x chewable gummies/day, matched to shape and color without active ingredient)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMPASS global performance measures | Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University) | Following 12 weeks of intervention | 
| Cognitive domain factor score | Speed of attention, accuracy of attention, speed of memory, accuracy of working memory, and accuracy of episodic memory measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University) | Following 12 weeks of intervention | 
| Location Learning score | Learning index, displacement score, and delayed recall score, measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University) | Following 12 weeks of intervention | 
| Rey Auditory Verbal Learning Test (RAVLT) | Learning score, Immediate recall, delayed recall, and delayed recognition measured by the Rey Auditory Verbal Learning Test | Following 12 weeks of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMPASS global performance measures | Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University) | Following 6 weeks of intervention | 
| Cognitive domain factor score | Speed of attention, accuracy of attention, speed of memory, accuracy of working memory, and accuracy of episodic memory measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University) | Following 6 weeks of intervention | 
| Location Learning score | Learning index, displacement score, and delayed recall score, measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University) | Following 6 weeks of intervention | 
| Rey Auditory Verbal Learning Test (RAVLT) | Learning score, Immediate recall, delayed recall, and delayed recognition measured by the Rey Auditory Verbal Learning Test | Following 6 weeks of intervention | 
| Individual cognitive task score | Individual tasks include the following: immediate word recall, simple reaction time, choice reaction time, 4 choice reaction time, arrows flankers, digit vigilance, rapid visual information processing, Stroop, Corsi blocks, numeric working memory, 2-back, delayed word recall, delayed picture recognition, and delayed word recognition measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University) | Following 6 and 12 weeks of intervention | 
| Children's Sleep Habits Questionnaire (CSHQ) | 23 items questionnaire completed by the parent, with a 3-point scale where a higher score is indicative of more disturbed sleep. | Following 6 and 12 weeks of intervention | 
| Children's Sleep self-report (SSR) questionnaire | 26 items questionnaire completed by the child with a 3-point scale where a higher score is indicative of more disturbed sleep. | Following 6 and 12 weeks of intervention | 
| Sleep measures | Sleep actigraphy device (measuring: sleep onset, total sleep time (TST), wake after sleep onset (WASO), awakenings, average awakening, efficiency) and sleep duration as reported in a sleep diary. | Following 12 weeks of intervention | 
| Parent Visual Analogue Scales (VAS) | 100 mm VAS in which the parent rates their child via the following parameters: Attention, performance at school, performance of schoolwork at home, happiness, and stress. | Following 6 and 12 weeks of intervention | 
| Child mood Visual Analogue Scales (VAS) | 100 mm VAS questionnaire in which the child rates their own mood via the following parameters: Relaxed, alert, jittery, tense, tired, headache, overall mood, mental fatigue, performance, happy/sad, and stress /calm | Following 6 and 12 weeks of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition, Phosphatidylserine, Memory, Learning, Attention