Trials / Completed
CompletedNCT03705572
Intervention Study Investigating the Effect of a Phospholipid Drink on Cognitive Performance in 6-8 Year Old School Children
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- University of Leeds · Academic / Other
- Sex
- All
- Age
- 6 Years – 8 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | Lacprodan PL20 | Milk protein concentrate that is high in phospholipid content (min 16%). |
| OTHER | Placebo | Placebo milk drink. |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2015-04-01
- Completion
- 2015-04-01
- First posted
- 2018-10-15
- Last updated
- 2018-10-15
Source: ClinicalTrials.gov record NCT03705572. Inclusion in this directory is not an endorsement.