Cognition Intervention Study Dortmund

Cognition - Other Clinical Trial

— CogniDO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01401153
• Other study ID #: COG0611DO
• Secondary ID: 03MT110527328495
• Status: Completed
• Phase: N/A
• First received: July 19, 2011
• Last updated: October 9, 2012
• Start date: May 2011
• Est. completion date: July 2011

Study information

• Verified date: October 2012
• Source: Research Institute of Child Nutrition, Dortmund
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 15 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Metabolic diseases or special diet

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cognition - Other

Intervention

Other:
• Skipping lunch
Just water.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Child Nutrition, Dortmund

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tonic Alertness (Mean Reaction Time)	Mean reaction time to response to a simple visual stimulus without a preceding warning signal	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Tonic Alertness (Deviation of Reaction Time)	Deviation of reaction time --> logarithmic standard deviation of the reaction times	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Tonic Alertness (Commission Errors)	Reactions when no stimulus had been presented	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Tonic Alertness (Omission Errors)	Stimuli to which no reaction follows within 1.5s	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Immediate Block Span	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)	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Incorrect Immediate Block Span	Number of sequences incorrectly reproduced	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Correct Immediate Block Span	Number of sequences correctly reproduced	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Sequencing Errors	Sequences including all the blocks of a prescribed sequence, but in the wrong order	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Reactions	Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Percentage Incorrect Reactions	Percentage of incorrect reactions	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Number Correct Reactions	Number of correct reactions	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Incorrect Reactions	Number of incorrect reactions	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Mean Time Correct Reactions	Mean time to react correctly	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Mean Time Incorrect Reactions	Mean time to react incorrectly	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No