Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI)

Cognitive Function Clinical Trial

— CogniDo-GI  

Official title:

Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02763371
• Other study ID #: COG0416DO
• Status: Recruiting
• Phase: N/A
• First received: April 28, 2016
• Last updated: May 3, 2016
• Start date: April 2016
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: Research Institute of Child Nutrition, Dortmund
• Contact: Mathilde Kersting, Prof
• Phone: 023179221018
• Email: kersting[@]fke-do.de
• 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 The Cognition Intervention Study Dortmund Continued (Coco) connected 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. The present study the Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) examines the influence of the gylcemic index of lunch on cognitive performance of school children in the afternoon.

Description:

Glucose is the main fuel of the human brain. However, which impact the glycemic index of lunch has on cognitive performance is not clear. A recently published review by Philippou and Constantinou suggested cautiously that a low-GI meal may favor cognitive functions in adults, but note that their findings are inconclusive due to differences in study design, study sample (e.g. size, age), time of testing and the cognitive domain being examined. Because of cerebral particularities, children may react highly sensitive to variations of glycose 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.

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. lunch with a high GI-rice or a low GI-rice and a water beverage, 12.45 p.m. to 13.15 p.m. regular lunch break, 13.15 p.m. computerized tests of executive cognitive and basal (alertness) functioning.

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: Recruiting
• Enrollment: 200
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• 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:
• Dietary: high GI lunch
High GI: High-GI rice lunch ad libitum on test day 1 and low GI-rice lunch on test day 2. Water at libitum was constantly available on both days.
• Dietary: low GI lunch
Low-GI: Low GI-rice lunch ad libitum on test day 1 and high GI-rice lunch on test day 2. Water at libitum was constantly available on both days.

Locations

Country	Name	City	State
Germany	Germany Research Institute of Child Nutrition	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.; a. Non-switch: digits from 1 to 26 in random order are to put in order. b. Non-switch: Same as a) with letters from A to Z c. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)	participants were tested on two test days (T1 and T2) with one week wash out	No
Primary	Shifting: Change of total reaction time for b) [ms	Measuring global task-switching costs by a three-part computer trial.; a. Non-switch: digits from 1 to 26 in random order are to put in order. b. Non-switch: Same as a) with letters from A to Z c. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)	participants were tested on two test days (T1 and T2) with one week wash out	No
Primary	Shifting: Change of total switch-costs [ms	Measuring global task-switching costs by a three-part computer trial.; a. Non-switch: digits from 1 to 26 in random order are to put in order. b. Non-switch: Same as a) with letters from A to Z c. switch: digits 1 to 13 and letters A to M in random order to put in altering ascending order (digit, letter)	participants were tested on two test days (T1 and T2) with one week wash out	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.	participants were tested on two test days (T1 and T2) with one week wash out	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.	participants were tested on two test days (T1 and T2) with one week wash out	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.	participants were tested on two test days (T1 and T2) with one week wash out	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	participants were tested on two test days (T1 and T2) with one week wash out	No
Primary	tonic alertness: change of deviation of reaction time [ms]	measures the level of alertness in response to a simple visual stimulus. Deviation of reaction time	participants were tested on two test days (T1 and T2) with one week wash out	No
Primary	tonic alertness:change of numbers of omission errors [n]	measures the level of alertness in response to a simple visual stimulus. subsidiary outcome is the numbers of omission errors.	participants were tested on two test days (T1 and T2) with one week wash out	No
Primary	tonic alertness:change of numbers of commission errors [n]	measures the level of alertness in response to a simple visual stimulus. subsidiary outcome is the numbers of comission errors.	participants were tested on two test days (T1 and T2) with one week wash out	No