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Completed

NCT Number: NCT03705572

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

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.

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Key information

Conditions

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lacprodan PL20

Dietary Supplement

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

Placebo

Other

Placebo milk drink.

Primary outcomes

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

    Time frame: Week 0, week 3 & week 6

    Test of immediate and delayed verbal memory recall.

Secondary outcomes

  1. Motor Screening Task (CANTAB suite) change from baseline

    Time frame: Week 0, week 3 & week 6

    To identify motor impairment. Dependent variables: reaction time for each trial and distance from cross.

  2. Spatial Recognition Memory (CANTAB suite) change from baseline

    Time frame: Week 0, week 3 & week 6

    Dependent variables: number of correct trials and reaction time for each trial.

  3. Spatial Span (CANTAB suite) change from baseline

    Time frame: Week 0, week 3 & week 6

    Dependent variables: highest span reached, number of correct responses, number of incorrect responses and reaction time for each trial.

  4. Reaction time (CANTAB suite) change from baseline

    Time frame: Week 0, week 3 & week 6

    Dependent variables: mental reaction time and movement time for each trial, number of correct responses, number of incorrect responses and number of invalid responses. Two parts to the task included simple, one response option, and choice, 5 response options.

  5. Subjective mood questionnaire change from baseline

    Time frame: Week 0, week 3 & week 6

    Visual Analogue Scale.

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Arla Foods

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 15, 2018
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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