Cognition Intervention Study Dortmund- Continued (Coco)

Cognitive Function Clinical Trial

— Coco  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02344056
• Other study ID #: RIChildNutrition
• Status: Completed
• Phase: N/A
• First received: December 15, 2014
• Last updated: April 28, 2016
• Start date: October 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 14 Years

Eligibility

Inclusion Criteria:

• All fifth and 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

• Cognitive Function

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Research Institute of Child Nutrition, Dortmund	Dortmund

Sponsors (1)

Lead Sponsor	Collaborator
Research Institute of Child Nutrition, Dortmund

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shifting: Change of total reaction time for a) [ms]	Measuring global task-switching costs by a three-part computer trial.; Non-switch: digits from 1 to 26 in random order are to put in order.; Non-switch: Same as a) with letters from A to Z; switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Shifting: Change of total reaction time for b) [ms]	Measuring global task-switching costs by a three-part computer trial.; Non-switch: digits from 1 to 26 in random order are to put in order.; Non-switch: Same as a) with letters from A to Z; switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	Shifting: Change of total switch-costs [ms]	Measuring global task-switching costs by a three-part computer trial.; Non-switch: digits from 1 to 26 in random order are to put in order.; Non-switch: Same as a) with letters from A to Z; switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)	Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	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: Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	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: Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	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: Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	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: Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	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: Participants were tested twice with one week wash out (1h after having/skipping lunch)	No
Primary	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: Participants were tested twice with one week wash out (1h after having/skipping lunch)	No