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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 主要终点
- Rivermead Behavioural Memory Test for Children (RBMT-C) change from baseline
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Dietary Supplement: Phospholipid drink.
Participant in an intervention parallel group consumed a drink with added phospholipids (Lacprodan PL20).
干预措施: Lacprodan PL20 (Dietary Supplement)
Dietary Supplement: Placebo milk drink.
Participant in an intervention parallel group consumed a drink without added phospholipids.
干预措施: Placebo (Other)
结局指标
主要结局
Rivermead Behavioural Memory Test for Children (RBMT-C) change from baseline
时间窗: Week 0, week 3 & week 6
Test of immediate and delayed verbal memory recall.
次要结局
- Subjective mood questionnaire change from baseline(Week 0, week 3 & week 6)
- Spatial Recognition Memory (CANTAB suite) change from baseline(Week 0, week 3 & week 6)
- Motor Screening Task (CANTAB suite) change from baseline(Week 0, week 3 & week 6)
- Spatial Span (CANTAB suite) change from baseline(Week 0, week 3 & week 6)
- Reaction time (CANTAB suite) change from baseline(Week 0, week 3 & week 6)
研究者
Prof Louise Dye
Professor
University of Leeds