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

NCT05177978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2022-09-28

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • International Flavors & Fragrances Inc.

    collaborator UNKNOWN

  • Northumbria University

    lead OTHER

Principal Investigators

  • Philippa Jackson · Northumbria University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-02
Primary Completion
2022-08-14
Completion
2022-08-14

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05177978 on ClinicalTrials.gov