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Trial record 7 of 180 for:    Phospholipids

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

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ClinicalTrials.gov Identifier: NCT03705572
Recruitment Status : Completed
First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Collaborator:
Arla Foods
Information provided by (Responsible Party):
Prof Louise Dye, University of Leeds

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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Lacprodan PL20 Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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
Study Start Date : May 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Active Comparator: Dietary Supplement: Phospholipid drink.
Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20).
Dietary Supplement: 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.
Other: Placebo
Placebo milk drink.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Subjective mood questionnaire change from baseline [ Time Frame: Week 0, week 3 & week 6 ]
    Visual Analogue Scale.



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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03705572


Sponsors and Collaborators
University of Leeds
Arla Foods
Investigators
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Principal Investigator: Louise Dye, PhD Professor of Nutrition & Behaviour; Lead for Strategic Development.
Principal Investigator: Clare Lawton, PhD Associate Professor of Nutrition & Behaviour.

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Responsible Party: Prof Louise Dye, Professor, University of Leeds
ClinicalTrials.gov Identifier: NCT03705572     History of Changes
Other Study ID Numbers: Arla02
First Posted: October 15, 2018    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof Louise Dye, University of Leeds:
Milk
Lacprodan PL20
Glycerophospholipids
Cognition