Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI) (CogniDo-GI)

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.

Study Overview

• Status: Unknown
• Conditions: Cognitive Function
• Intervention / Treatment: Other: Dietary: high GI lunch; Other: Dietary: low GI lunch

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dortmund, Germany, 44225
    • Recruiting
    • Germany Research Institute of Child Nutrition
    • Contact: Mathilde Kersting, Professor; Phone Number: 023179221018; Email: kersting@fke-do.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary: high GI lunch; 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.	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.
Experimental: Dietary: low GI lunch; 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.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Research Institute of Child Nutrition, Dortmund
• Investigators: Study Chair: Mathilde Kersting, Prof, Research Institut of Child Nutrition

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 28, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 5, 2016

Study Record Updates

• Last Update Posted (Estimate): May 5, 2016
• Last Update Submitted That Met QC Criteria: May 3, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: high GI lunch; low GI lunch
• Other Study ID Numbers: COG0416DO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No