Having LunchCogniDoNCT02082444
Cognition Intervention Study PLUS (CogniDO PLUS)
A study testing Skipping lunch in people with Having Lunch and Omitting Lunch, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
Trial summary
Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically proven insights into cognitive effects of lunch to the existing recommendations for school meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. Read more about this study
- Who is it for?
- Ages 10 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Having Lunch, Omitting Lunch
- What is being tested?
- Skipping lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2013to Dec 2013
- 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 13 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, epilepsy or special diet
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognition Intervention Study PLUS (CogniDO PLUS): Short-term Effects of Lunch on Children's Executive Cognitive Functions
Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically proven insights into cognitive effects of lunch to the existing recommendations for school meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. As an enhancement of CogniDo this study investigates the short-term effects of having school lunch versus skipping it on children's executive cognitive functions in the afternoon. The study was conducted in a comprehensive school in Gelsenkirchen (Germany) and included 215 children.
Read the detailed description
Because of cerebral particularities, children may react highly sensitive to short-term 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. computerized tests of executive 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 program developed by the Institute of Working Learning and Aging (Institut für Arbeiten Lernen Altern, ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents. Migration background was requested from teachers. Body Mass Index was calculated based on measured height and weight.
- Conditions
- Having Lunch, Omitting Lunch
- 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
Also called 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 at libitum was constantly 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.
• Shifting
Measuring global task-switching costs by a three-part computer trial.
- Non-switch, or 'repeated' condition: The digits from 1 to 26 are presented to the participant in a random order with the task to put them in order.
- Non-switch, or 'repeated' condition: The letters from A to Z are presented to the participant in a random order with the task to put them in order.
- switch: the digits from 1 to 13 and the letters from A to M are presented to the participant in a random order with the task to put them in following order: digit (starting at 1), letter (starting at A), next higher digit, following letter etc.
Measured: Participants were tested twice with one week wash out (1h after having/skipping lunch)
• updating
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: Participants were tested twice with one week wash out (1h after having/skipping lunch)
• inhibition
In one item three superposed triangles are presented to the participants, each pointing independently either to the left or the right. In addition, only the triangle in the middle might have no top and, thus, neither pointing to the left nor the right. The participant is supposed to press the buttons left, right or no reaction according to the direction of the triangle in the middle. The outer triangles appear 0.5 ms before the one in the middle. In total, this trial consists of 102 items.
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 posted10 Mar 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Having LunchStudies 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
- 193 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
- NCT02082444
- Sponsor's protocol ID
- CogPlus201314
- Acronym
- CogniDo
- Status last verified
- Mar 2014
- First submitted
- 6 Mar 2014
- Last updated
- 10 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition Intervention Study PLUS (CogniDO PLUS): Short-term Effects of Lunch on Children's Executive Cognitive Functions
- ClinicalTrials.gov ID
- NCT02082444
- Acronym / sponsor ID
- CogniDo / CogPlus201314
- Conditions
- Having Lunch, Omitting Lunch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- Research Institute of Child Nutrition, DortmundUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 10 Mar 2014 (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.
Major aim of the Cognition Intervention Study Dortmund (CogniDo) was to add scientifically proven insights into cognitive effects of lunch to the existing recommendations for school meals in Germany. The Cognition Intervention Study Dortmund PLUS ties up to that aim. As an enhancement of CogniDo this study investigates the short-term effects of having school lunch versus skipping it on children's executive cognitive functions in the afternoon. The study was conducted in a comprehensive school in Gelsenkirchen (Germany) and included 215 children.
Detailed description
Because of cerebral particularities, children may react highly sensitive to short-term 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. computerized tests of executive 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 program developed by the Institute of Working Learning and Aging (Institut für Arbeiten Lernen Altern, ALA). Usual eating behaviour, sleep behaviour, physical activity and parental education were determined as control variables by questionnaires for children, parents. Migration background was requested from teachers. Body Mass Index was calculated based on measured height and weight.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| 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 at libitum was constantly available on both days. |
Who may qualify
- Ages
- 10 to 13 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, epilepsy 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 lunchAlso: Just water | Other | Having lunch/skipping lunch |
Primary outcome
• Shifting
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, or 'repeated' condition: The digits from 1 to 26 are presented to the participant in a random order with the task to put them in order. 2. Non-switch, or 'repeated' condition: The letters from A to Z are presented to the participant in a random order with the task to put them in order. 3. switch: the digits from 1 to 13 and the letters from A to M are presented to the participant in a random order with the task to put them in following order: digit (starting at 1), letter (starting at A), next higher digit, following letter etc.
• updating
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.
• inhibition
Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
In one item three superposed triangles are presented to the participants, each pointing independently either to the left or the right. In addition, only the triangle in the middle might have no top and, thus, neither pointing to the left nor the right. The participant is supposed to press the buttons left, right or no reaction according to the direction of the triangle in the middle. The outer triangles appear 0.5 ms before the one in the middle. In total, this trial consists of 102 items.
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 10 Mar 2014.
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 Skipping lunch in people with Having Lunch and Omitting Lunch, 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 10 Mar 2014. 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 (time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)). The study lists 3 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 10 Mar 2014.