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

NCT05177978 | Completed

• 1 other identifier: 39BZ1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change

Keywords

Cognition; Phosphatidylserine; Memory; Learning; Attention

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• COMPASS global performance measures

  Following 6 weeks of intervention

• Cognitive domain factor score

  Following 6 weeks of intervention

• Location Learning score

  Following 6 weeks of intervention

• Rey Auditory Verbal Learning Test (RAVLT)

  Following 6 weeks of intervention

• Individual cognitive task score

  Following 6 and 12 weeks of intervention

Study Arms (2)

Phosphatidylserine

EXPERIMENTAL

100 mg elemental phosphatidylserine

Dietary Supplement: Phosphatidylserine

Placebo

PLACEBO COMPARATOR

Placebo comparator

Dietary Supplement: Placebo

Interventions

Phosphatidylserine DIETARY_SUPPLEMENT

Phosphatidylserine containing supplement (2 x chewable gummies/day; Total daily dose of 100 mg elemental phosphatidylserine)

Phosphatidylserine

Placebo DIETARY_SUPPLEMENT

Placebo comparator (2 x chewable gummies/day, matched to shape and color without active ingredient)

Placebo

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead
• International Flavors & Fragrances Inc.: collaborator

Study Sites (1)

Brain, Performance, Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, Tyne & Wear, NE1 8ST, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 41318468 DERIVED

MeSH Terms

Interventions

Phosphatidylserines

Intervention Hierarchy (Ancestors)

Glycerophospholipids; Phosphatidic Acids; Glycerophosphates; Phospholipids; Membrane Lipids; Lipids

Study Officials

• Philippa Jackson

  Northumbria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: January 5, 2022
• Study Start: November 2, 2020
• Primary Completion: August 14, 2022
• Study Completion: August 14, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

GB (1)