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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Lacprodan PL20
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dietary Supplement: Phospholipid drink.<br>Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20). | Dietary Supplement: Lacprodan PL20<br>* Milk protein concentrate that is high in phospholipid content (min 16%).<br>|
| Placebo Comparator: Dietary Supplement: Placebo milk drink.<br>Participant in an intervention parallel group consumed a drink without added phospholipids. | Other: Placebo<br>* Placebo milk drink.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Screening Task (CANTAB suite) change from baseline | To identify motor impairment. Dependent variables: reaction time for each trial and distance from cross. | Week 0, week 3 & week 6 | 
| Spatial Recognition Memory (CANTAB suite) change from baseline | Dependent variables: number of correct trials and reaction time for each trial. | Week 0, week 3 & week 6 | 
| Spatial Span (CANTAB suite) change from baseline | Dependent variables: highest span reached, number of correct responses, number of incorrect responses and reaction time for each trial. | Week 0, week 3 & week 6 | 
| Reaction time (CANTAB suite) change from baseline | 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. | Week 0, week 3 & week 6 | 
| Subjective mood questionnaire change from baseline | Visual Analogue Scale. | Week 0, week 3 & week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Milk, Lacprodan PL20, Glycerophospholipids, Cognition