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

NCT ID: NCT05177978

Last Updated: 2022-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-02
• Study Completion Date: 2022-08-14

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Phosphatidylserine

100 mg elemental phosphatidylserine

Group Type: EXPERIMENTAL

Phosphatidylserine

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

Placebo comparator

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Phosphatidylserine

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

International Flavors & Fragrances Inc.

UNKNOWN

Sponsor Role: collaborator

Northumbria University

OTHER

Sponsor Role: lead

Responsible Party

Philippa Jackson

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philippa Jackson

Role: PRINCIPAL_INVESTIGATOR

Northumbria University

Locations

Brain, Performance, Nutrition Research Centre, Northumbria University

Newcastle upon Tyne, Tyne & Wear, United Kingdom

Countries

United Kingdom

Other Identifiers

39BZ1

Identifier Type: -

Identifier Source: org_study_id