Cognitive FunctionCocoNCT02344056
Cognition Intervention Study Dortmund- Continued (Coco)
A study testing Having lunch/skipping lunch and Skipping lunch/having lunch in people with Cognitive Function, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
Trial summary
The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive functions in the afternoon. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Having lunch/skipping lunch and Skipping lunch/having lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Mar 2015
- 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 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents and child
Who cannot join
- Metabolic diseases or special diet
Trial locations and contacts
1 site in 1 country.
About this study
The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive functions in the afternoon. The present Coco study connect this two previous studies and investigates the effect of having school lunch versus skipping it on children's basal and executive cognitive functions later in the afternoon.
Read the detailed description
Because of cerebral particularities, children may react highly sensitive to variations of nutrient supply. Therefore, an optimised composition of meals at favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering for lunch at school. However, the number of 'meal skippers' is increasing among children and adolescents. Thus, the effect of skipping lunch 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 mid-morning is standardized. The intervention is integrated in 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 water as a beverage (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. to 14.10 p.m. regular school lesson. 14.15 p.m. computerized tests of executive cognitive and basal (alertness) functioning, 3 p.m. lunch for the 'skipping meal'-group. Parameters of cognition with relevance to everyday school life are measured by a computerized test program developed by the Institute of Working Learning and Aging (ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents.
- Conditions
- Cognitive Function
- Being tested
- Having lunch/skipping lunch, Skipping lunch/having lunch
- Keywords
- Having Lunch, Skipping Lunch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Having lunch/skipping lunchOther
Lunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days.
Skipping lunch/having lunchOther
No lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days.
| 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 at libitum was constantly available on both days. Receives: Other: Having lunch/skipping lunch |
| skipping lunch/having lunch | Experimental | no lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days. Receives: Other: Skipping lunch/having lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shifting: Change of total reaction time for a) [ms]
Measuring global task-switching costs by a three-part computer trial.
- Non-switch: digits from 1 to 26 in random order are to put in order.
- Non-switch: Same as a) with letters from A to Z
- switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Shifting: Change of total reaction time for b) [ms]
Measuring global task-switching costs by a three-part computer trial.
- Non-switch: digits from 1 to 26 in random order are to put in order.
- Non-switch: Same as a) with letters from A to Z
- switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Shifting: Change of total switch-costs [ms]
Measuring global task-switching costs by a three-part computer trial.
- Non-switch: digits from 1 to 26 in random order are to put in order.
- Non-switch: Same as a) with letters from A to Z
- switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
updating: change of ratio of missing [%]
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
Measured: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
updating: change of ratio of false alarms [%]
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
Measured: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
updating: change of mean reaction time [ms]
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
Measured: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
tonic alertness: change of mean reaction time [ms]
measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.
Measured: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
tonic alertness: change of deviation of reaction time [ms]
measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.
Measured: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
tonic alertness:change of numbers of omission and commission errors [n]
measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.
Measured: Time Frame: 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 posted22 Jan 2015 (estimated)
- Study startOct 2014
- Primary completionMar 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies 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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Institute of Child Nutrition, Dortmund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344056
- Sponsor's protocol ID
- RIChildNutrition
- Acronym
- Coco
- Status last verified
- May 2015
- First submitted
- 15 Dec 2014
- Last updated
- 29 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition Intervention Study Dortmund- Continued (Coco)
- ClinicalTrials.gov ID
- NCT02344056
- Acronym / sponsor ID
- Coco / RIChildNutrition
- Conditions
- Cognitive Function
- Keywords
- Having Lunch, Skipping Lunch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Research Institute of Child Nutrition, DortmundUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 22 Jan 2015 (estimated)
- 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.
The Cognition Intervention Study Dortmund (CogniDo) and the Cognition Intervention Study Dortmund PLUS (CogniDo PLUS) investigated the short-term effects of having school lunch versus skipping it on children's basal (CogniDo) and executive (CogniDo PLUS) cognitive functions in the afternoon. The present Coco study connect this two previous studies and investigates the effect of having school lunch versus skipping it on children's basal and executive cognitive functions later in the afternoon.
Detailed description
Because of cerebral particularities, children may react highly sensitive to variations of nutrient supply. Therefore, an optimised composition of meals at favourable mealtime should be considered for optimal cognitive performance. The increasing implementation of all-day schools in Germany requires the children's catering for lunch at school. However, the number of 'meal skippers' is increasing among children and adolescents. Thus, the effect of skipping lunch 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 mid-morning is standardized. The intervention is integrated in 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 water as a beverage (intervention of 'skipping meal'), 12.45 p.m. to 1.15 p.m. regular lunch break, 1.15 p.m. to 14.10 p.m. regular school lesson. 14.15 p.m. computerized tests of executive cognitive and basal (alertness) functioning, 3 p.m. lunch for the 'skipping meal'-group. Parameters of cognition with relevance to everyday school life are measured by a computerized test program developed by the Institute of Working Learning and Aging (ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| having lunch/skipping lunch | Experimental | Other: Having lunch/skipping lunchLunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days. |
| skipping lunch/having lunch | Experimental | Other: Skipping lunch/having lunchno lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All fifth and 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 |
|---|---|---|
| Having lunch/skipping lunchLunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days. | Other | having lunch/skipping lunch |
| Skipping lunch/having lunchNo lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days. | Other | skipping lunch/having lunch |
Primary outcome
Shifting: Change of total reaction time for a) [ms]
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Measuring global task-switching costs by a three-part computer trial. 1. Non-switch: digits from 1 to 26 in random order are to put in order. 2. Non-switch: Same as a) with letters from A to Z 3. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)
Shifting: Change of total reaction time for b) [ms]
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Measuring global task-switching costs by a three-part computer trial. 1. Non-switch: digits from 1 to 26 in random order are to put in order. 2. Non-switch: Same as a) with letters from A to Z 3. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)
Shifting: Change of total switch-costs [ms]
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Measuring global task-switching costs by a three-part computer trial. 1. Non-switch: digits from 1 to 26 in random order are to put in order. 2. Non-switch: Same as a) with letters from A to Z 3. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)
updating: change of ratio of missing [%]
Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
updating: change of ratio of false alarms [%]
Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
updating: change of mean reaction time [ms]
Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Continuous monitoring and quick addition or deletion of contents within the working memory A sequence of 106 items (pictures of fruit and vegetables) is shown to the participants. A reaction is required if the actual shown item was equal to the item shown in the second to last.
tonic alertness: change of mean reaction time [ms]
Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.
tonic alertness: change of deviation of reaction time [ms]
Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.
tonic alertness:change of numbers of omission and commission errors [n]
Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measures the level of alertness in response to a simple visual stimulus. Mean reaction time and the deviation of reaction time; subsidiary outcomes are the numbers of omission and commission errors.
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 29 Apr 2016.
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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 Having lunch/skipping lunch and Skipping lunch/having lunch in people with Cognitive Function, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
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 29 Apr 2016. 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 Germany. 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?
Shifting: Change of total reaction time for a) [ms] (time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)). The study lists 9 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 29 Apr 2016.