HealthyNCT03705572
Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children
A study testing Lacprodan PL20 in people with Healthy, run by University of Leeds.
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. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lacprodan PL20
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
About this study
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
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.
Read the 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
- Being tested
- Lacprodan PL20, Placebo
- Keywords
- Milk, Lacprodan PL20, Glycerophospholipids, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacprodan PL20Dietary supplement
Milk protein concentrate that is high in phospholipid content (min 16%).
PlaceboOther
Placebo milk drink.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement: Phospholipid drink. | Active comparator | Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20). Receives: Dietary Supplement: Lacprodan PL20 |
| Dietary Supplement: Placebo milk drink. | Placebo comparator | Participant in an intervention parallel group consumed a drink without added phospholipids. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rivermead Behavioural Memory Test for Children (RBMT-C) change from baseline
Test of immediate and delayed verbal memory recall.
Measured: Week 0, week 3 & week 6
Secondary outcomes (5)
Motor Screening Task (CANTAB suite) change from baseline
To identify motor impairment. Dependent variables: reaction time for each trial and distance from cross.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 0, week 3 & week 6
Subjective mood questionnaire change from baseline
Visual Analogue Scale.
Measured: Week 0, week 3 & week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study startMay 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Responsible party
- Principal investigator, Prof Louise Dye, University of Leeds
- Investigators
- Louise Dye, PhD, Principal investigator, Professor of Nutrition & Behaviour; Lead for Strategic Development.Clare Lawton, PhD, Principal investigator, Associate Professor of Nutrition & Behaviour.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705572
- Sponsor's protocol ID
- Arla02
- Status last verified
- Oct 2018
- First submitted
- 7 Jul 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03705572
- Acronym / sponsor ID
- Arla02
- Conditions
- Healthy
- Keywords
- Milk, Lacprodan PL20, Glycerophospholipids, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- May 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement: Phospholipid drink. | Active comparator | Dietary Supplement: Lacprodan PL20Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20). |
| Dietary Supplement: Placebo milk drink. | Placebo comparator | Other: PlaceboParticipant in an intervention parallel group consumed a drink without added phospholipids. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacprodan PL20Milk protein concentrate that is high in phospholipid content (min 16%). | Dietary supplement | Dietary Supplement: Phospholipid drink. |
| PlaceboPlacebo milk drink. | Other | Dietary Supplement: Placebo milk drink. |
Primary outcome
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.
5 secondary outcomes
Motor Screening Task (CANTAB suite) change from baseline
Time frame: Week 0, week 3 & week 6
Spatial Recognition Memory (CANTAB suite) change from baseline
Time frame: Week 0, week 3 & week 6
Spatial Span (CANTAB suite) change from baseline
Time frame: Week 0, week 3 & week 6
Reaction time (CANTAB suite) change from baseline
Time frame: Week 0, week 3 & week 6
Subjective mood questionnaire change from baseline
Time frame: Week 0, week 3 & week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louise Dye, PhD principal investigator
Professor of Nutrition & Behaviour; Lead for Strategic Development.
Clare Lawton, PhD principal investigator
Associate Professor of Nutrition & Behaviour.
Questions about this trial
What is this clinical trial studying?
A study testing Lacprodan PL20 in people with Healthy, run by University of Leeds.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rivermead Behavioural Memory Test for Children (RBMT-C) change from baseline (time frame: Week 0, week 3 & week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018; AzTrials last refreshed its copy on 2 Nov 2026.