Clinical trial NCT03705572: Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children
Official title: A Randomised, Double-blind, Parallel Groups, Placebo-controlled 6 Week Human Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Milk
Lacprodan PL20
Glycerophospholipids
Cognition
Lead sponsor: University of Leeds
Sponsor class: OTHER
Collaborators: name: Arla Foods
First posted: 2018-10-15
Enrollment: 165
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: A randomised, double blind, placebo controlled study with parallel groups investigating a 6 week intervention in 6-8 year old school children of phospholipid containing milk drink vs. placebo milk drink. Participants were familiarised with the test battery and IQ (Wechsler abbreviated scale of intelligence) and colour blindness (Ishihara test) measurements were taken prior to the intervention. Milk drink taste testing and milk preference selection was also carried out prior to the intervention. The test battery was administered at baseline (week 0), midpoint (week 3) and endpoint (week 6), and the milk intervention was given Monday - Friday at school shortly before their mid-morning break over a 6 week period. This study design, including both the test days and morning milk supplementation, was intended to emulate the children's normal routine as far as possible. The milk drink was a supplement to the children's usual diet.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Rivermead Behavioural Memory Test for Children (RBMT-C) change from baseline
timeFrame: Week 0, week 3 & week 6
Secondary outcomes:
measure: Motor Screening Task (CANTAB suite) change from baseline
timeFrame: Week 0, week 3 & week 6
measure: Spatial Recognition Memory (CANTAB suite) change from baseline
timeFrame: Week 0, week 3 & week 6
measure: Spatial Span (CANTAB suite) change from baseline
timeFrame: Week 0, week 3 & week 6
measure: Reaction time (CANTAB suite) change from baseline
timeFrame: Week 0, week 3 & week 6
measure: Subjective mood questionnaire change from baseline
timeFrame: Week 0, week 3 & week 6
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Nutrition & Behaviour; Lead for Strategic Development.
name: Louise Dye, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor of Nutrition & Behaviour.
name: Clare Lawton, PhD
role: PRINCIPAL_INVESTIGATOR
References: