HealthyNCT03979027
Acute Effects of Breakfast Compared With No Breakfast on Cognitive Function and Subjective State in 11-13 Year Old Children
A study testing Breakfast: ready-to-eat-cereal and milk in people with Healthy, run by University of Leeds at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Breakfast: ready-to-eat-cereal and milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2011to 28 Apr 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Appetite Research Unit, University of Leeds
Leeds, West Yorkshire, LS29JT
About this study
Official 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
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.
Read the 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
- Conditions
- Healthy
- Being tested
- Breakfast: ready-to-eat-cereal and milk
- Keywords
- Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breakfast: ready-to-eat-cereal and milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Breakfast: ready-to-eat-cereal and milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Paired Associates Learning (PAL) performance
Paired Associates Learning (PAL) task was administered on individual touchscreen portable computers.
Measured: baseline, 70 minutes post-intervention.
Secondary outcomes (15)
Simple Reaction Time task performance
Reaction time assessed by Simple Reaction Time (SRT) task. The task was administered on individual touchscreen portable computers.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 70 minutes, and 215 minutes post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start4 Jan 2011
- Primary completion28 Apr 2011
- Study completion28 Apr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Kellogg Company
- Responsible party
- Principal investigator, Prof Louise Dye, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979027
- Sponsor's protocol ID
- RTECCOG1113
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33609174
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT03979027
- Acronym / sponsor ID
- RTECCOG1113
- Conditions
- Healthy
- Keywords
- Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Kellogg Company
- Study start
- 4 Jan 2011 (actual)
- Primary completion
- 28 Apr 2011 (actual)
- Study completion
- 28 Apr 2011 (actual)
- First posted
- 7 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Breakfast | No intervention | –Fasting. Ad libitum water intake permitted. |
| Breakfast | Experimental | Dietary Supplement: Breakfast: ready-to-eat-cereal and milkAd 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. |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breakfast: ready-to-eat-cereal and milk | Dietary supplement | Breakfast |
Primary outcome
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.
15 secondary outcomes
Simple Reaction Time task performance
Time frame: baseline, 70 minutes and 215 minutes post-intervention
5-Choice Reaction Time task performance
Time frame: baseline, 70 minutes and 215 minutes post-intervention
Rapid Visual Information Processing task (RVIP) performance
Time frame: baseline, 70 minutes and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of hunger
Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of cheerfulness
Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of energy
Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of motivation to try hard
Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of ease of distraction
Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of ease of focusing
Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of feeling of awake
Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of bad temperedness
Time frame: baseline, 15 minutes, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of cognitive test battery difficulty
Time frame: baseline, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of concentration during the cognitive test battery
Time frame: baseline, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of performance on the cognitive test battery
Time frame: baseline, 70 minutes, and 215 minutes post-intervention
Subjective unipolar visual analogue scale ratings of frustration during the cognitive test battery
Time frame: baseline, 70 minutes, and 215 minutes post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Derived from this study: PubMed 33609174Adolphus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breakfast: ready-to-eat-cereal and milk in people with Healthy, run by University of Leeds at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Paired Associates Learning (PAL) performance (time frame: baseline, 70 minutes post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03979027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.