Acute Effects of Breakfast Compared With No Breakfast on Cognitive Function and Subjective State in 11-13 Year Old Children

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Breakfast: ready-to-eat-cereal and milk

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

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS29JT
      • Human Appetite Research Unit, University of Leeds

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Breakfast; Fasting. Ad libitum water intake permitted.
Experimental: Breakfast; 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.	Dietary supplement: Breakfast: ready-to-eat-cereal and milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline Paired Associates Learning (PAL) performance	Paired Associates Learning (PAL) task was administered on individual touchscreen portable computers.	baseline, 70 minutes post-intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simple Reaction Time task performance	Reaction time assessed by Simple Reaction Time (SRT) task. The task was administered on individual touchscreen portable computers.	baseline, 70 minutes and 215 minutes post-intervention
5-Choice Reaction Time task performance	Reaction time assessed by 5-Choice Reaction Time (5-CRT) task. The task was administered on individual touchscreen portable computers.	baseline, 70 minutes and 215 minutes post-intervention
Rapid Visual Information Processing task (RVIP) performance	Visual sustained attention assessed by Rapid Visual Information Processing task (RVIP). The task was administered on individual touchscreen portable computers.	baseline, 70 minutes and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of hunger	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their current state. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a worse outcome	baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of cheerfulness	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their current state. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a better outcome.	baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of energy	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their current state. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a better outcome.	baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of motivation to try hard	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their current state. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a better outcome	baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of ease of distraction	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their current state. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a worse outcome	baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of ease of focusing	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their current state. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a better outcome	baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of feeling of awake	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their current state. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a better outcome	baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of bad temperedness	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their current state. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a worse outcome	baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of cognitive test battery difficulty	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their cognitive test battery experience. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a worse outcome	baseline, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of concentration during the cognitive test battery	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their cognitive test battery experience. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a better outcome	baseline, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of performance on the cognitive test battery	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their cognitive test battery experience. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a better outcome	baseline, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of frustration during the cognitive test battery	The unipolar Visual Analogue Scale is a horizontal line, 100mm in length, anchored by the extreme intensities of a single subjective feeling (e.g. 'not at all' to 'very'). The participant marks on the line at the point that they feel represents their perception of their cognitive test battery experience. Participants responded to each Visual Analogue Scale using a touch screen computer by moving the cursor along a 100mm line with extreme anchors at each end. The initial location of the cursor was at the 50mm mark. There were 100 points on the scale, yielding possible scores of 0-100. Higher scores indicate a worse outcome	baseline, 70 minutes, and 215 minutes post-intervention

Collaborators and Investigators

• Sponsor: University of Leeds
• Collaborators: Kellogg Company

Publications and helpful links

General Publications

• Adolphus K, Hoyland A, Walton J, Quadt F, Lawton CL, Dye L. Ready-to-eat cereal and milk for breakfast compared with no breakfast has a positive acute effect on cognitive function and subjective state in 11-13-year-olds: a school-based, randomised, controlled, parallel groups trial. Eur J Nutr. 2021 Sep;60(6):3325-3342. doi: 10.1007/s00394-021-02506-2. Epub 2021 Feb 20.

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2011
• Primary Completion (Actual): April 28, 2011
• Study Completion (Actual): April 28, 2011

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 6, 2019
• First Posted (Actual): June 7, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2019
• Last Update Submitted That Met QC Criteria: June 6, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Cognition
• Other Study ID Numbers: RTECCOG1113

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No