Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children

NCT03705572 | Completed

• 1 other identifier: Arla02
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

Six week RCT intervention on the effects of phospholipid containing milk drink vs. placebo milk drink on cognitive performance in 6-8 year old school children.

Conditions

Healthy

Keywords

Milk; Lacprodan PL20; Glycerophospholipids; Cognition

Outcome Measures

Primary Outcomes (1)

• Rivermead Behavioural Memory Test for Children (RBMT-C) change from baseline

  Test of immediate and delayed verbal memory recall.

  Week 0, week 3 & week 6

Secondary Outcomes (5)

• Motor Screening Task (CANTAB suite) change from baseline

  Week 0, week 3 & week 6

• Spatial Recognition Memory (CANTAB suite) change from baseline

  Week 0, week 3 & week 6

• Spatial Span (CANTAB suite) change from baseline

  Week 0, week 3 & week 6

• Reaction time (CANTAB suite) change from baseline

  Week 0, week 3 & week 6

• Subjective mood questionnaire change from baseline

  Week 0, week 3 & week 6

Study Arms (2)

Dietary Supplement: Phospholipid drink.

ACTIVE COMPARATOR

Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20).

Dietary Supplement: Lacprodan PL20

Dietary Supplement: Placebo milk drink.

PLACEBO COMPARATOR

Participant in an intervention parallel group consumed a drink without added phospholipids.

Other: Placebo

Interventions

Lacprodan PL20 DIETARY_SUPPLEMENT

Milk protein concentrate that is high in phospholipid content (min 16%).

Dietary Supplement: Phospholipid drink.

Placebo OTHER

Placebo milk drink.

Dietary Supplement: Placebo milk drink.

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Male or female, aged 6-8 years.
• Willingness to consume milk drinks during the study determined by a score of \>5 on a taste testing Likert scale for at least one flavour of the milk drinks.
• Ability to follow verbal and simple written instructions in English.
• Normal vision, with appropriate corrective lenses if required.
• Ability to understand cognitive testing instructions and responding requirements.

You may not qualify if:

• Poor general health.
• Colour blindness.
• Behavioural difficulties or attention disorders (e.g. Attention Deficit Hyperactivity Disorder).
• Learning disabilities that interfere with the ability to understand written or verbal communications.
• Inability to understand the objective of the cognitive tests, or carry out the tests.
• Any food allergies or intolerances (e.g. lactose intolerance).
• Acute illness, or feelings of unwell, within the week prior to testing.
• Current administration of any psychotropic medication or supplementation in the month prior to testing, or during testing.
• Hearing impairment that precludes the ability to follow verbal instructions.
• Children already receiving milk at school unless parents are willing to substitute current milk with the study milk.

Sponsors & Collaborators

• University of Leeds: lead
• Arla Foods: collaborator

MeSH Terms

Interventions

lacprodan PL-20

Study Officials

• Louise Dye, PhD

  Professor of Nutrition & Behaviour; Lead for Strategic Development.

  PRINCIPAL INVESTIGATOR

• Clare Lawton, PhD

  Associate Professor of Nutrition & Behaviour.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: October 15, 2018
• Study Start: May 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: October 15, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share