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CompletedNCT02344056CocoUpdated Apr 29, 2016

Cognition Intervention Study Dortmund- Continued (Coco)

An interventional study of Having lunch/skipping lunch and Skipping lunch/having lunch in Cognitive Function, sponsored by Research Institute of Child Nutrition, Dortmund. Completed at 1 site in Germany. Open to participants aged 10 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-04-29.

Sponsored by Research Institute of Child Nutrition, Dortmund · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
154
Allocation
Randomized
Ages
10 Years to 14 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Cognitive Function

Keywords

  • Having Lunch
  • Skipping Lunch
03

In context

Lead sponsor

Research Institute of Child Nutrition, Dortmund is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents and child

Exclusion criteria

Exclusion Criteria:

  • Metabolic diseases or special diet
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
154 participants (actual)

Study arms

  • Experimental
    having lunch/skipping lunch

    Lunch 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

  • Experimental
    skipping lunch/having lunch

    no 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

Interventions

  • OtherHaving lunch/skipping lunch

    Lunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days.

  • OtherSkipping lunch/having lunch

    No lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days.

06

What researchers measure

Primary outcomes

  1. Shifting: Change of total reaction time for a) [ms]

    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)

    Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

  2. Shifting: Change of total reaction time for b) [ms]

    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)

    Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

  3. Shifting: Change of total switch-costs [ms]

    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)

    Time frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

  4. 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.

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

  5. 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.

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

  6. 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.

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

  7. 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.

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

  8. 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.

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

  9. 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.

    Time frame: Time Frame: Participants were tested twice with one week wash out (1h after having/skipping lunch)

07

Study locations

1 site
  • Research Institute of Child Nutrition, Dortmund
    Dortmund, 44225, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2014
First posted
Jan 22, 2015
Start
Oct 2014
Primary completionActual
Mar 2015
CompletionActual
Mar 2015
Last update
Apr 29, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02344056
Lead sponsor
Research Institute of Child Nutrition, Dortmund
Responsible party
Sponsor
First posted
Jan 22, 2015
Start date
Oct 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Apr 29, 2016
View the source record on ClinicalTrials.gov ↗

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