NCT02763371

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

April 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

May 5, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

April 28, 2016

Last Update Submit

May 3, 2016

Conditions

Cognitive Function

Keywords

high GI lunchlow GI lunch

Outcome Measures

Primary Outcomes (10)

  • 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

Study Arms (2)

Dietary: high GI lunch

EXPERIMENTAL

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

Dietary: low GI lunch

EXPERIMENTAL

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

Interventions

Dietary: high GI lunchOTHER

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: high GI lunch
Dietary: low GI lunchOTHER

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.

Dietary: low GI lunch

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Metabolic diseases or special diet

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Germany Research Institute of Child Nutrition

Dortmund, Dortmund, 44225, Germany

RECRUITING

Study Officials

  • Mathilde Kersting, Prof

    Research Institut of Child Nutrition

    STUDY CHAIR

Central Study Contacts

Mathilde Kersting, Prof

CONTACT

023179221018kersting@fke-do.de

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2016

First Posted

May 5, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

May 5, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)