NCT05177978

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Northumbria University · Academic / Other
• Sex: All
• Age: 8 Years – 12 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Phosphatidylserine	Phosphatidylserine containing supplement (2 x chewable gummies/day; Total daily dose of 100 mg elemental phosphatidylserine)
DIETARY_SUPPLEMENT	Placebo	Placebo comparator (2 x chewable gummies/day, matched to shape and color without active ingredient)

Timeline

• Start date: 2020-11-02
• Primary completion: 2022-08-14
• Completion: 2022-08-14
• First posted: 2022-01-05
• Last updated: 2022-09-28

Locations

1 site across 1 country: United Kingdom