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| Name | Class |
|---|---|
| International Flavors & Fragrances Inc. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phosphatidylserine | Experimental | 100 mg elemental phosphatidylserine |
|
| Placebo | Placebo Comparator | Placebo comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phosphatidylserine | Dietary Supplement | Phosphatidylserine containing supplement (2 x chewable gummies/day; Total daily dose of 100 mg elemental phosphatidylserine) |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippa Jackson | Northumbria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain, Performance, Nutrition Research Centre, Northumbria University | Newcastle upon Tyne | Tyne & Wear | NE1 8ST | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41318468 | Derived | Friling M, Jackson PA, Kennedy D, Dodd F, Smith E, Lavie A, Lopresti A, Ivanir E, Jalanka J. The cognitive effects of supplementation with sunflower phosphatidyl serine in healthy children aged 8 to 12 years: a randomized controlled trial. Nutr J. 2025 Nov 29;25(1):3. doi: 10.1186/s12937-025-01264-9. |
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| Placebo | Dietary Supplement | Placebo comparator (2 x chewable gummies/day, matched to shape and color without active ingredient) |
|
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 |
| ID | Term |
|---|---|
| D010718 | Phosphatidylserines |
| ID | Term |
|---|---|
| D020404 | Glycerophospholipids |
| D010712 | Phosphatidic Acids |
| D005994 | Glycerophosphates |
| D010743 | Phospholipids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
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