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Completed

NCT Number: NCT01401153

Cognition Intervention Study Dortmund

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.

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Key information

Conditions

Cognition - Other

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Metabolic diseases or special diet

Treatment and study plan

Skipping lunch

Other

Just water.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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)

  6. 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

  7. 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

  8. 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

  9. 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)

  10. Percentage Incorrect Reactions

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

    Percentage of incorrect reactions

  11. Number Correct Reactions

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

    Number of correct reactions

  12. Incorrect Reactions

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

    Number of incorrect reactions

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Research Institute of Child Nutrition, Dortmund

Other

Registry information

Official study title

Cross-over Trial Determining the Short-term Effects of Lunch on Children's Cognitive Functioning

Acronym: CogniDO

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Jul 25, 2011
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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