Cognition - OtherCogniDONCT01401153
Cognition Intervention Study Dortmund
A study testing Skipping lunch in people with Cognition - Other, run by Research Institute of Child Nutrition, Dortmund.
Trial summary
Major aim of this study is to add scientifically proven insights into cognitive effects of meals to the existing recommendations for school meals in Germany. As a first step the short-term effects of skipping lunch on children's cognitive functioning in the afternoon will be examined in a cross-over trial. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition - Other
- What is being tested?
- Skipping lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 10 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All sixth grade students of Gesamtschule Berger Feld with the consent of parents and child
Who cannot join
- Metabolic diseases or special diet
About this study
Official title: Cross-over Trial Determining the Short-term Effects of Lunch on Children's Cognitive Functioning
Major aim of this study is to add scientifically proven insights into cognitive effects of meals to the existing recommendations for school meals in Germany. As a first step the short-term effects of skipping lunch on children's cognitive functioning in the afternoon will be examined in a cross-over trial. The study is conducted in a large comprehensive school in Gelsenkirchen (Germany) including about 150 children.
Read the detailed description
Because of cerebral particularities, children may react sensitive to short-term variations of nutrient supply. Therefore, an optimised composition of meals at nutritionally favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering at school. However, also the number of 'meal skippers' is increasing among children. Thus, the effect of skipping of the midday meal at school on cognitive functioning is examined in this experimental cross-over trial.
As prior intake of food can have an influence on the physiological effect of test meal, the children's dietary intake in the morning is standardized. The intervention is integrated in the usual everyday school life:
9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m. everyday school life, 12.25 p.m. either lunch (control) or only a non-caloric beverage (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. computerized tests of cognitive functioning, 2 p.m. lunch for the 'skipping meal'-group.
Parameters of cognition with relevance to everyday school life are measured by a computerized test battery of the 'Wiener Testsystem'. Usual eating behaviour, sleep behaviour, physical activity, parental education and migration background are determined as control variables by questionnaires for children, parents and teachers. Beside the Body Mass Index, the individual IQ is measured by a paper-pencil-test.
- Conditions
- Cognition - Other
- Being tested
- Skipping lunch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skipping lunchOther
Just water.
| Study group | Role | What they receive |
|---|---|---|
| Having lunch/skipping lunch | Experimental | Lunch ad libitum on test day 1 and no lunch on test day 2. Water available on both days. Receives: Other: Skipping lunch |
| Skipping lunch/having lunch | Experimental | No lunch on test day 1 and lunch ad libitum on test day 2. Water available on both days. Receives: Other: Skipping lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tonic Alertness (Mean Reaction Time)
Mean reaction time to response to a simple visual stimulus without a preceding warning signal
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Tonic Alertness (Deviation of Reaction Time)
Deviation of reaction time --> logarithmic standard deviation of the reaction times
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Tonic Alertness (Commission Errors)
Reactions when no stimulus had been presented
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Tonic Alertness (Omission Errors)
Stimuli to which no reaction follows within 1.5s
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Immediate Block Span
Longest sequence correctly reproduced in at least two of three items (the test is a task of reproducing prescribed sequences from two to eight blocks)
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Incorrect Immediate Block Span
Number of sequences incorrectly reproduced
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Correct Immediate Block Span
Number of sequences correctly reproduced
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Sequencing Errors
Sequences including all the blocks of a prescribed sequence, but in the wrong order
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Reactions
Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Percentage Incorrect Reactions
Percentage of incorrect reactions
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Number Correct Reactions
Number of correct reactions
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Incorrect Reactions
Number of incorrect reactions
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Mean Time Correct Reactions
Mean time to react correctly
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Mean Time Incorrect Reactions
Mean time to react incorrectly
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startMay 2011
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cognition - OtherStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Child Nutrition, Dortmund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde Kersting, Prof. Dr., Study director, Research Institute of Child Nutrition, Dortmund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401153
- Sponsor's protocol ID
- COG0611DO
- Other IDs
- 03MT110527328495
- Acronym
- CogniDO
- Status last verified
- Oct 2012
- First submitted
- 19 Jul 2011
- Last updated
- 9 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-over Trial Determining the Short-term Effects of Lunch on Children's Cognitive Functioning
- ClinicalTrials.gov ID
- NCT01401153
- Acronym / sponsor ID
- CogniDO / COG0611DO
- Conditions
- Cognition - Other
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Research Institute of Child Nutrition, DortmundUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 25 Jul 2011 (estimated)
- Results
- Posted 9 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major aim of this study is to add scientifically proven insights into cognitive effects of meals to the existing recommendations for school meals in Germany. As a first step the short-term effects of skipping lunch on children's cognitive functioning in the afternoon will be examined in a cross-over trial. The study is conducted in a large comprehensive school in Gelsenkirchen (Germany) including about 150 children.
Detailed description
Because of cerebral particularities, children may react sensitive to short-term variations of nutrient supply. Therefore, an optimised composition of meals at nutritionally favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering at school. However, also the number of 'meal skippers' is increasing among children. Thus, the effect of skipping of the midday meal at school on cognitive functioning is examined in this experimental cross-over trial.
As prior intake of food can have an influence on the physiological effect of test meal, the children's dietary intake in the morning is standardized. The intervention is integrated in the usual everyday school life:
9.15 a.m. standardized snack within the frame of the regular break, 9.45 a.m. to 12.25 p.m. everyday school life, 12.25 p.m. either lunch (control) or only a non-caloric beverage (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. computerized tests of cognitive functioning, 2 p.m. lunch for the 'skipping meal'-group.
Parameters of cognition with relevance to everyday school life are measured by a computerized test battery of the 'Wiener Testsystem'. Usual eating behaviour, sleep behaviour, physical activity, parental education and migration background are determined as control variables by questionnaires for children, parents and teachers. Beside the Body Mass Index, the individual IQ is measured by a paper-pencil-test.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Having lunch/skipping lunch | Experimental | Other: Skipping lunchLunch ad libitum on test day 1 and no lunch on test day 2. Water available on both days. |
| Skipping lunch/having lunch | Experimental | Other: Skipping lunchNo lunch on test day 1 and lunch ad libitum on test day 2. Water available on both days. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All sixth grade students of Gesamtschule Berger Feld with the consent of parents and child
Key exclusion criteria (1 listed)
- Metabolic diseases or special diet
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 |
|---|---|---|
| Skipping lunchJust water. | Other | Having lunch/skipping lunch, Skipping lunch/having lunch |
Primary outcome
Tonic Alertness (Mean Reaction Time)
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Mean reaction time to response to a simple visual stimulus without a preceding warning signal
Tonic Alertness (Deviation of Reaction Time)
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Deviation of reaction time --> logarithmic standard deviation of the reaction times
Tonic Alertness (Commission Errors)
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Reactions when no stimulus had been presented
Tonic Alertness (Omission Errors)
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Stimuli to which no reaction follows within 1.5s
Immediate Block Span
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Longest sequence correctly reproduced in at least two of three items (the test is a task of reproducing prescribed sequences from two to eight blocks)
Incorrect Immediate Block Span
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Number of sequences incorrectly reproduced
Correct Immediate Block Span
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Number of sequences correctly reproduced
Sequencing Errors
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Sequences including all the blocks of a prescribed sequence, but in the wrong order
Reactions
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)
Percentage Incorrect Reactions
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Percentage of incorrect reactions
Number Correct Reactions
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Number of correct reactions
Incorrect Reactions
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Number of incorrect reactions
Mean Time Correct Reactions
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Mean time to react correctly
Mean Time Incorrect Reactions
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Mean time to react incorrectly
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mathilde Kersting, Prof. Dr. study director
Research Institute of Child Nutrition, Dortmund
Questions about this trial
What is this clinical trial studying?
A study testing Skipping lunch in people with Cognition - Other, run by Research Institute of Child Nutrition, Dortmund.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 9 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 9 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tonic Alertness (Mean Reaction Time) (time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2012.