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Clinical Trials/NCT03979027
NCT03979027
Completed
Not Applicable

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 site in 1 country234 target enrollmentJanuary 4, 2011
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Leeds
Enrollment
234
Locations
1
Primary Endpoint
Change from baseline Paired Associates Learning (PAL) performance
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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

Registry
clinicaltrials.gov
Start Date
January 4, 2011
End Date
April 28, 2011
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof Louise Dye

Professor Louise Dye

University of Leeds

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change from baseline Paired Associates Learning (PAL) performance

Time Frame: baseline, 70 minutes post-intervention.

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

Secondary Outcomes

  • 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)

Study Sites (1)

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