Cognitive ChangeNCT05177978
The Cognitive Effects of 6- and 12-weeks Administration of a Food Supplement Containing Phosphatidylserine in Healthy Children Aged 8 to 12 Years
A study testing Phosphatidylserine in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Phosphatidylserine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2020to 14 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance, Nutrition Research Centre, Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8ST
About this study
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
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.
- Conditions
- Cognitive Change
- Being tested
- Phosphatidylserine, Placebo
- Keywords
- Cognition, Phosphatidylserine, Memory, Learning, Attention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhosphatidylserineDietary supplement
Phosphatidylserine containing supplement (2 x chewable gummies/day; Total daily dose of 100 mg elemental phosphatidylserine)
PlaceboDietary supplement
Placebo comparator (2 x chewable gummies/day, matched to shape and color without active ingredient)
| Study group | Role | What they receive |
|---|---|---|
| Phosphatidylserine | Experimental | 100 mg elemental phosphatidylserine Receives: Dietary Supplement: Phosphatidylserine |
| Placebo | Placebo comparator | Placebo comparator Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
COMPASS global performance measures
Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Following 12 weeks of intervention
Secondary outcomes (10)
COMPASS global performance measures
Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Following 6 and 12 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start2 Nov 2020
- Primary completion14 Aug 2022
- Study completion14 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive ChangeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- International Flavors & Fragrances Inc.
- Responsible party
- Principal investigator, Philippa Jackson, Northumbria University
- Investigators
- Philippa Jackson, Principal investigator, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177978
- Sponsor's protocol ID
- 39BZ1
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2021
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41318468
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05177978
- Acronym / sponsor ID
- 39BZ1
- Conditions
- Cognitive Change
- Keywords
- Cognition, Phosphatidylserine, Memory, Learning, Attention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- International Flavors & Fragrances Inc.
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 14 Aug 2022 (actual)
- Study completion
- 14 Aug 2022 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phosphatidylserine | Experimental | Dietary Supplement: Phosphatidylserine100 mg elemental phosphatidylserine |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo comparator |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhosphatidylserinePhosphatidylserine containing supplement (2 x chewable gummies/day; Total daily dose of 100 mg elemental phosphatidylserine) | Dietary supplement | Phosphatidylserine |
| PlaceboPlacebo comparator (2 x chewable gummies/day, matched to shape and color without active ingredient) | Dietary supplement | Placebo |
Primary outcome
COMPASS global performance measures
Time frame: Following 12 weeks of intervention
Speed of performance, and accuracy of performance measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Cognitive domain factor score
Time frame: Following 12 weeks of intervention
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)
Location Learning score
Time frame: Following 12 weeks of intervention
Learning index, displacement score, and delayed recall score, measured by Computerised Mental Performance Assessment System (COMPASS, Northumbria University)
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Following 12 weeks of intervention
Learning score, Immediate recall, delayed recall, and delayed recognition measured by the Rey Auditory Verbal Learning Test
10 secondary outcomes
COMPASS global performance measures
Time frame: Following 6 weeks of intervention
Cognitive domain factor score
Time frame: Following 6 weeks of intervention
Location Learning score
Time frame: Following 6 weeks of intervention
Rey Auditory Verbal Learning Test (RAVLT)
Time frame: Following 6 weeks of intervention
Individual cognitive task score
Time frame: Following 6 and 12 weeks of intervention
Children's Sleep Habits Questionnaire (CSHQ)
Time frame: Following 6 and 12 weeks of intervention
Children's Sleep self-report (SSR) questionnaire
Time frame: Following 6 and 12 weeks of intervention
Sleep measures
Time frame: Following 12 weeks of intervention
Parent Visual Analogue Scales (VAS)
Time frame: Following 6 and 12 weeks of intervention
Child mood Visual Analogue Scales (VAS)
Time frame: Following 6 and 12 weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Derived from this study: PubMed 41318468Friling 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippa Jackson principal investigator
Northumbria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phosphatidylserine in people with Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COMPASS global performance measures (time frame: Following 12 weeks of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05177978, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.