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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03705572
• Other study ID #: Arla02
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2018
• Source: University of Leeds
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Lacprodan PL20
Milk protein concentrate that is high in phospholipid content (min 16%).

Other:
• Placebo
Placebo milk drink.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Leeds	Arla Foods

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subjective mood questionnaire change from baseline	Visual Analogue Scale.	Week 0, week 3 & week 6