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| Name | Class |
|---|---|
| Arla Foods | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dietary Supplement: Phospholipid drink. | Active Comparator | Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20). |
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| Dietary Supplement: Placebo milk drink. | Placebo Comparator | Participant in an intervention parallel group consumed a drink without added phospholipids. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lacprodan PL20 | Dietary Supplement | Milk protein concentrate that is high in phospholipid content (min 16%). |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise Dye, PhD | Professor of Nutrition & Behaviour; Lead for Strategic Development. | Principal Investigator |
| Clare Lawton, PhD | Associate Professor of Nutrition & Behaviour. | Principal Investigator |
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| ID | Term |
|---|---|
| C000592132 | lacprodan PL-20 |
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| Placebo | Other | Placebo milk drink. |
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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 |