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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Breakfast: ready-to-eat-cereal and milk


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Breakfast<br>Fasting. Ad libitum water intake permitted. | |
| Experimental: Breakfast<br>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<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition