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

NCT ID: NCT03705572

Last Updated: 2018-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 165 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-04-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Dietary Supplement: Phospholipid drink.

Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20).

Group Type: ACTIVE_COMPARATOR

Lacprodan PL20

Intervention Type: DIETARY_SUPPLEMENT

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

Dietary Supplement: Placebo milk drink.

Participant in an intervention parallel group consumed a drink without added phospholipids.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo milk drink.

Interventions

Lacprodan PL20

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo milk drink.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Arla Foods

INDUSTRY

Sponsor Role: collaborator

University of Leeds

OTHER

Sponsor Role: lead

Responsible Party

Prof Louise Dye

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Louise Dye, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Nutrition & Behaviour; Lead for Strategic Development.

Clare Lawton, PhD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Nutrition & Behaviour.

Other Identifiers

Arla02

Identifier Type: -

Identifier Source: org_study_id