Clinical trial NCT01401153: Cognition Intervention Study Dortmund
Official title: Cross-over Trial Determining the Short-term Effects of Lunch on Children's Cognitive Functioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition - Other
Lead sponsor: Research Institute of Child Nutrition, Dortmund
Sponsor class: OTHER
First posted: 2011-07-25
Enrollment: 105
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Metabolic diseases or special diet

Primary outcomes:
measure: Tonic Alertness (Mean Reaction Time)
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Tonic Alertness (Deviation of Reaction Time)
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Tonic Alertness (Commission Errors)
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Tonic Alertness (Omission Errors)
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Immediate Block Span
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Incorrect Immediate Block Span
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Correct Immediate Block Span
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Sequencing Errors
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Reactions
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Percentage Incorrect Reactions
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Number Correct Reactions
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Incorrect Reactions
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Mean Time Correct Reactions
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
measure: Mean Time Incorrect Reactions
timeFrame: Participants were tested twice with one week wash out (1h after having/skipping lunch)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Research Institute of Child Nutrition, Dortmund
name: Mathilde Kersting, Prof. Dr.
role: STUDY_DIRECTOR
References: