Skip to main content
OpenTrials
Completed

NCT Number: NCT03979027

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

11 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Human Appetite Research Unit, University of Leeds

Leeds, West Yorkshire, LS29JT, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breakfast: ready-to-eat-cereal and milk

Dietary Supplement

Primary outcomes

  1. 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

  1. Simple Reaction Time task performance

    Time frame: baseline, 70 minutes and 215 minutes post-intervention

    Reaction time assessed by Simple Reaction Time (SRT) task. The task was administered on individual touchscreen portable computers.

  2. 5-Choice Reaction Time task performance

    Time frame: baseline, 70 minutes and 215 minutes post-intervention

    Reaction time assessed by 5-Choice Reaction Time (5-CRT) task. The task was administered on individual touchscreen portable computers.

  3. Rapid Visual Information Processing task (RVIP) performance

    Time frame: baseline, 70 minutes and 215 minutes post-intervention

    Visual sustained attention assessed by Rapid Visual Information Processing task (RVIP). The task was administered on individual touchscreen portable computers.

  4. Subjective unipolar visual analogue scale ratings of hunger

    Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

    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

  5. Subjective unipolar visual analogue scale ratings of cheerfulness

    Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

    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.

  6. Subjective unipolar visual analogue scale ratings of energy

    Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

    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.

  7. Subjective unipolar visual analogue scale ratings of motivation to try hard

    Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

    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

  8. Subjective unipolar visual analogue scale ratings of ease of distraction

    Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

    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

  9. Subjective unipolar visual analogue scale ratings of ease of focusing

    Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

    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

  10. Subjective unipolar visual analogue scale ratings of feeling of awake

    Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

    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

  11. Subjective unipolar visual analogue scale ratings of bad temperedness

    Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention

    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

  12. Subjective unipolar visual analogue scale ratings of cognitive test battery difficulty

    Time frame: baseline, 70 minutes, and 215 minutes post-intervention

    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

  13. Subjective unipolar visual analogue scale ratings of concentration during the cognitive test battery

    Time frame: baseline, 70 minutes, and 215 minutes post-intervention

    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

  14. Subjective unipolar visual analogue scale ratings of performance on the cognitive test battery

    Time frame: baseline, 70 minutes, and 215 minutes post-intervention

    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

  15. Subjective unipolar visual analogue scale ratings of frustration during the cognitive test battery

    Time frame: baseline, 70 minutes, and 215 minutes post-intervention

    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

Sponsors and collaborators

Lead sponsor

University of Leeds

Other

Collaborators

  • Kellogg Company

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jun 7, 2019
Registry last updated
Jun 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.