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临床试验/NCT03979027
NCT03979027已完成不适用

Acute Effects of Breakfast Compared With No Breakfast on Cognitive Function and Subjective State in 11-13 Year Old Children: A School-based, Randomised, Controlled, Parallel Groups Trial

University of Leeds1 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2011年1月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
234
试验地点
1
主要终点
Change from baseline Paired Associates Learning (PAL) performance

研究概览

简要总结

This study is a school-based, randomised, controlled, parallel groups trial to examine the acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive function and subjective state in 11-13 year old adolescents. It was hypothesised that the consumption of breakfast will have a positive acute effect on cognitive performance and subjective state compared with breakfast omission in 11-13 year olds.

详细描述

This study is a school-based, randomised, controlled, parallel groups trial to examine the acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive function and subjective state in 11-13 year old adolescents. It was hypothesised that the consumption of breakfast will have a positive acute effect on cognitive performance and subjective state compared with breakfast omission in 11-13 year olds. The study sample consisted of males and females aged 11-13 years who were recruited to take part in the study from a UK secondary school. There were two conditions in this parallel groups study: Breakfast and No breakfast (fasting). The breakfast intervention consisted of ad libitum intake of ready-to-eat-cereal with milk. Cognitive function was assessed at baseline and +70 and +215 minutes post-intervention. The Cambridge Neuro-psychological Test Automated Battery (CANTAB; Cambridge Cognition Ltd) was used to assess cognitive function. The battery included: Simple Reaction Time (SRT), 5-Choice Reaction Time (5-CRT), Rapid Visual Information Processing (RVIP), and Paired Associates Learning (PAL), which measured reaction time, visual-sustained attention, and visual-spatial memory respectively. Concomitant ratings of subjective mood, alertness, satiety, and motivation were taken throughout the morning using eight unipolar Visual Analogue Scales

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
None

入排标准

年龄范围
11 Years 至 13 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •The inclusion criteria were as follows: aged 11-13 years, willingness to consume RTEC with semi-skimmed cow's milk during the study, ability to follow verbal and written instructions in English, and normal vision with appropriate corrective lenses if required. The

排除标准

  • •were as follows: inability to understand the objective of the cognitive tests or carry out the tests, behavioural difficulties or attention disorders, administration of any psychotropic medication in the month prior to testing or during testing, food allergies or intolerances which prevent consumption of RTEC and milk (e.g. coeliac, lactose intolerance), acute illness or feeling unwell within the week prior to testing or during testing, and hearing impairment that precluded the normal use of headphones.

研究组 & 干预措施

No Breakfast

No Intervention

Fasting. Ad libitum water intake permitted.

Breakfast

Experimental

Ad libitum intake of ready-to-eat-cereal with milk. Participants were given a choice of four commercially available RTECs with 1.8% fat cow's milk. Ad libitum water intake was also permitted. The four ready-to-eat-cereals were corn flakes, toasted rice, shredded whole wheat pieces with a sugar topping, and wheat, corn and oat shapes.

干预措施: Breakfast: ready-to-eat-cereal and milk (Dietary Supplement)

结局指标

主要结局

Change from baseline Paired Associates Learning (PAL) performance

时间窗: baseline, 70 minutes post-intervention.

Paired Associates Learning (PAL) task was administered on individual touchscreen portable computers.

次要结局

  • 5-Choice Reaction Time task performance(baseline, 70 minutes and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of motivation to try hard(baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention)
  • Rapid Visual Information Processing task (RVIP) performance(baseline, 70 minutes and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of energy(baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of hunger(baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of cheerfulness(baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of performance on the cognitive test battery(baseline, 70 minutes, and 215 minutes post-intervention)
  • Simple Reaction Time task performance(baseline, 70 minutes and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of bad temperedness(baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of ease of distraction(baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of ease of focusing(baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of cognitive test battery difficulty(baseline, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of feeling of awake(baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of frustration during the cognitive test battery(baseline, 70 minutes, and 215 minutes post-intervention)
  • Subjective unipolar visual analogue scale ratings of concentration during the cognitive test battery(baseline, 70 minutes, and 215 minutes post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Louise Dye

Professor Louise Dye

University of Leeds

研究点 (1)

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