Clinical trial NCT02763371: Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI)
Official title: Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Function
Keywords: high GI lunch
low GI lunch
Lead sponsor: Research Institute of Child Nutrition, Dortmund
Sponsor class: OTHER
First posted: 2016-05-05
Enrollment: 200
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Shifting: Change of total reaction time for a) [ms]
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: Shifting: Change of total reaction time for b) [ms
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: Shifting: Change of total switch-costs [ms
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: updating: change of ratio of missing [%]
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: updating: change of ratio of false alarms [%]
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: updating: change of mean reaction time [ms]
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: tonic alertness: change of mean reaction time [ms]
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: tonic alertness: change of deviation of reaction time [ms]
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: tonic alertness:change of numbers of omission errors [n]
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
measure: tonic alertness:change of numbers of commission errors [n]
timeFrame: participants were tested on two test days (T1 and T2) with one week wash out
Secondary outcomes:
Other outcomes:
Locations:
city: Dortmund
country: Germany
facility: Germany Research Institute of Child Nutrition
Study officials:
affiliation: Research Institut of Child Nutrition
name: Mathilde Kersting, Prof
role: STUDY_CHAIR
References: