Cognition Intervention Study Dortmund

NCT01401153 | Completed Results

• 2 other identifiers: COG0611DO03MT110527328495
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

Major aim of this study is to add scientifically proven insights into cognitive effects of meals to the existing recommendations for school meals in Germany. As a first step the short-term effects of skipping lunch on children's cognitive functioning in the afternoon will be examined in a cross-over trial. The study is conducted in a large comprehensive school in Gelsenkirchen (Germany) including about 150 children.

Conditions

Cognition - Other

Outcome Measures

Primary Outcomes (14)

• Tonic Alertness (Mean Reaction Time)

  Mean reaction time to response to a simple visual stimulus without a preceding warning signal

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Tonic Alertness (Deviation of Reaction Time)

  Deviation of reaction time --\> logarithmic standard deviation of the reaction times

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Tonic Alertness (Commission Errors)

  Reactions when no stimulus had been presented

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Tonic Alertness (Omission Errors)

  Stimuli to which no reaction follows within 1.5s

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Immediate Block Span

  Longest sequence correctly reproduced in at least two of three items (the test is a task of reproducing prescribed sequences from two to eight blocks)

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Incorrect Immediate Block Span

  Number of sequences incorrectly reproduced

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Correct Immediate Block Span

  Number of sequences correctly reproduced

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Sequencing Errors

  Sequences including all the blocks of a prescribed sequence, but in the wrong order

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Reactions

  Number of total reactions (Subjects have to decide whether a displayed figure is identical with one of four figures shown or not)

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Percentage Incorrect Reactions

  Percentage of incorrect reactions

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Number Correct Reactions

  Number of correct reactions

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Incorrect Reactions

  Number of incorrect reactions

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Mean Time Correct Reactions

  Mean time to react correctly

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

• Mean Time Incorrect Reactions

  Mean time to react incorrectly

  Participants were tested twice with one week wash out (1h after having/skipping lunch)

Study Arms (2)

Having lunch/skipping lunch

EXPERIMENTAL

Lunch ad libitum on test day 1 and no lunch on test day 2. Water available on both days.

Other: Skipping lunch

Skipping lunch/having lunch

EXPERIMENTAL

No lunch on test day 1 and lunch ad libitum on test day 2. Water available on both days.

Other: Skipping lunch

Interventions

Skipping lunch OTHER

Just water.

Having lunch/skipping lunch; Skipping lunch/having lunch

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Metabolic diseases or special diet

Sponsors & Collaborators

• Research Institute of Child Nutrition, Dortmund: lead

Limitations and Caveats

* Open-label study, in which everyone involved knew about group assignment * Only one cognitive assessment per test day

Results Point of Contact

• Title: Prof. Dr. Mathilde Kersting
• Organization: Research Institute of Child Nutrition

kersting@fke-do.de

+49-231-792210-18

Study Officials

• Mathilde Kersting, Prof. Dr.

  Research Institute of Child Nutrition, Dortmund

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: July 19, 2011
• First Posted: July 25, 2011
• Study Start: May 1, 2011
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: November 9, 2012
• Results First Posted: November 9, 2012

Record last verified: 2012-10