- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03705572
Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children
October 12, 2018 updated by: Prof Louise Dye, University of Leeds
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
165
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 8 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Dietary Supplement: Phospholipid drink.
Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20).
|
Milk protein concentrate that is high in phospholipid content (min 16%).
|
Placebo Comparator: Dietary Supplement: Placebo milk drink.
Participant in an intervention parallel group consumed a drink without added phospholipids.
|
Placebo milk drink.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 0, week 3 & week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Week 0, week 3 & week 6
|
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.
|
Week 0, week 3 & week 6
|
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.
|
Week 0, week 3 & week 6
|
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.
|
Week 0, week 3 & week 6
|
Subjective mood questionnaire change from baseline
Time Frame: Week 0, week 3 & week 6
|
Visual Analogue Scale.
|
Week 0, week 3 & week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Louise Dye, PhD, Professor of Nutrition & Behaviour; Lead for Strategic Development.
- Principal Investigator: Clare Lawton, PhD, Associate Professor of Nutrition & Behaviour.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
July 7, 2016
First Submitted That Met QC Criteria
October 12, 2018
First Posted (Actual)
October 15, 2018
Study Record Updates
Last Update Posted (Actual)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 12, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Arla02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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