A Study of the Acute and Chronic Effects of 100% Florida Orange Juice Consumption on Cognitive Performance in 7-10 Year Old UK School Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Immediate and delayed picture recognition
研究概览
简要总结
This study is a 10-week intervention study to examine the acute and chronic effects of daily intake of a 100 % orange juice drink vs control drink on cognitive performance. The study aims to determine if there are any benefits of whole orange juice intake on cognitive performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an improvement in performance at week 10).
详细描述
This study will employ a randomised 10 week, parallel groups, double blind, placebo controlled design to investigate the effects of daily supplemental orange juice compared with an equicaloric placebo orange drink on cognitive performance in 7-10 year old school children. Following screening, participants will be randomly assigned to one of two conditions: (1) Active group: 100% orange juice, (2) Placebo group: control drink (containing equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour). Both the active and control groups will receive a drink daily for 10 weeks delivered as a school-based morning intervention administered by researchers. Children will also be given drinks to consume over the weekends and school holidays monitored by a drink intake diary. Participants, parents and teachers will be blind to their assigned condition. Researchers will also be blinded until completion of the data analysis.
Following a practise session at screening (week -1) to familiarise the participants with the cognitive tests and study drinks, participants will take part in 3 test sessions - at baseline (Week 0), on Day 1 of intervention (start of Week 1; acute effects) and immediately post intervention (end of Week 10; chronic effects).
At week -1 (screening) children will be tested for colour blindness (Ishihara test) and complete the Wechsler abbreviated scale of intelligence (WASI) for screening purposes. Respiratory peak flow, height, and weight will also be measured to examine the relationship between cognitive performance and physical activity.
This study design, including both the test day and morning juice supplementation, is intended to emulate the children's normal routine as far as possible. Each carton of juice will be provided mid-morning to act as a supplement to their usual diet.
Measures:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, aged 7-10 years
- •Willingness to consume test drinks during the study (determined by a score of 5 on the taste testing Likert scale for both orange juice drinks [attached])
- •Ability to follow verbal and simple written instructions in English
- •Ability to give written consent
- •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 (to be assessed at screening using Tests for Colour Blindness (Isihara, 1951)
- •Behavioural difficulties or attention disorders (e.g. Attention Deficit Hyperactivity Disorder)
- •Learning disabilities which 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 to study drinks
- •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
研究组 & 干预措施
100% OJ
240ml 100% Florida Orange Juice consumed on a daily basis for 10 weeks.
干预措施: 100% Florida OJ (Dietary Supplement)
Equicaloric Orange Drink
An equicaloric placebo orange drink (containing equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour) consumed daily for 10 weeks.
干预措施: Placebo Equicaloric Orange Drink (Dietary Supplement)
结局指标
主要结局
Immediate and delayed picture recognition
时间窗: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Primary dependent variable: number of pictures successfully recalled (from 20 presented) immediately following presentation and after a delay consisting of two cognitive tests (Corsi Tapping and Tower of Hanoi).
次要结局
- Delayed spatial memory(Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption)
- Tower of Hanoi (executive function)(Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption)
- Corsi block tapping test (Executive function and working memory)(Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption)
研究者
Prof Louise Dye
Professor
University of Leeds