Trial Outcomes & Findings for Cognition Intervention Study Dortmund (NCT NCT01401153)

NCT ID: NCT01401153

Last Updated: 2012-11-09

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 105 participants
• Primary outcome timeframe: Participants were tested twice with one week wash out (1h after having/skipping lunch)
• Results posted on: 2012-11-09

Participant Flow

Participants recruited from a secondary all-day school in Gelsenkirchen, Germany in May 2011

161 participants were assessed for eligibility; 40 children refused to participate; thus 121 children started the study; one-week wash out;

Participant milestones

Measure	Having Lunch Lunch ad libitum (pasta Bolognese, apple and water)	Skipping Lunch No lunch (water)
First Test Day STARTED	66	55
First Test Day COMPLETED	65	45
First Test Day NOT COMPLETED	1	10
Second Test Day STARTED	45	65
Second Test Day COMPLETED	45	60
Second Test Day NOT COMPLETED	0	5

Reasons for withdrawal

Measure	Having Lunch Lunch ad libitum (pasta Bolognese, apple and water)	Skipping Lunch No lunch (water)
First Test Day Learning disabilities; illness	1	10
Second Test Day illness	0	5

Baseline Characteristics

Cognition Intervention Study Dortmund

Baseline characteristics by cohort

Measure	Having Lunch n=66 Participants Lunch ad libitum (pasta Bolognese, apple and water)	Skipping Lunch n=55 Participants No lunch (water)	Total n=121 Participants Total of all reporting groups
Age, Categorical <=18 years	66 Participants n=5 Participants	55 Participants n=7 Participants	121 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	12.7 years STANDARD_DEVIATION 0.6 • n=5 Participants	12.7 years STANDARD_DEVIATION 0.6 • n=7 Participants	12.7 years STANDARD_DEVIATION 0.6 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	23 Participants n=7 Participants	57 Participants n=5 Participants
Region of Enrollment Germany	66 participants n=5 Participants	55 participants n=7 Participants	121 participants n=5 Participants

PRIMARY outcome

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

Population: Complete case analysis

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

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Tonic Alertness (Mean Reaction Time)	281 Milliseconds Interval 254.0 to 305.0	279 Milliseconds Interval 256.0 to 308.0

PRIMARY outcome

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

Population: Complete case analysis

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

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Tonic Alertness (Deviation of Reaction Time)	77 Unitless Interval 56.0 to 101.0	84 Unitless Interval 60.0 to 113.0

PRIMARY outcome

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

Population: Complete case analysis

Reactions when no stimulus had been presented

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Tonic Alertness (Commission Errors)	2 Commission errors Interval 0.0 to 3.0	2 Commission errors Interval 1.0 to 4.0

PRIMARY outcome

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

Population: Complete case analysis

Stimuli to which no reaction follows within 1.5s

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Tonic Alertness (Omission Errors)	0 Omission errors Interval 0.0 to 0.0	0 Omission errors Interval 0.0 to 1.0

PRIMARY outcome

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

Population: Complete case analysis

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)

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Immediate Block Span	5 Longest sequence correctly reproduced Interval 4.0 to 5.0	5 Longest sequence correctly reproduced Interval 4.0 to 5.0

PRIMARY outcome

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

Population: Complete case analysis

Number of sequences incorrectly reproduced

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Incorrect Immediate Block Span	2 Sequences incorrectly reproduced Interval 1.0 to 3.0	2 Sequences incorrectly reproduced Interval 1.0 to 3.0

PRIMARY outcome

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

Population: Complete case analysis

Number of sequences correctly reproduced

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Correct Immediate Block Span	10 Sequences correctly reproduced Interval 8.0 to 12.0	10 Sequences correctly reproduced Interval 8.0 to 12.0

PRIMARY outcome

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

Population: Complete case analysis

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

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Sequencing Errors	2 Sequences with wrong order Interval 1.0 to 3.0	2 Sequences with wrong order Interval 1.0 to 3.0

PRIMARY outcome

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

Population: Complete case analysis

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

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Reactions	628 Total reactions Interval 561.0 to 704.0	638 Total reactions Interval 574.0 to 739.0

PRIMARY outcome

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

Population: Complete case analysis

Percentage of incorrect reactions

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Percentage Incorrect Reactions	4.7 Incorrect reactions % Interval 2.6 to 7.7	5.3 Incorrect reactions % Interval 3.4 to 9.3

PRIMARY outcome

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

Population: Complete case analysis

Number of correct reactions

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Number Correct Reactions	586 Correct reactions Interval 533.0 to 656.0	594 Correct reactions Interval 532.0 to 670.0

PRIMARY outcome

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

Population: Complete case analysis

Number of incorrect reactions

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Incorrect Reactions	30 Incorrect reactions Interval 14.0 to 55.0	35 Incorrect reactions Interval 19.0 to 59.0

PRIMARY outcome

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

Population: Complete case analysis

Mean time to react correctly

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Mean Time Correct Reactions	0.6 Seconds Interval 0.6 to 0.7	0.6 Seconds Interval 0.5 to 0.7

PRIMARY outcome

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

Population: Complete case analysis

Mean time to react incorrectly

Outcome measures

Measure	Having Lunch n=105 Participants Lunch ad libitum	Skipping Lunch n=105 Participants No lunch (water)
Mean Time Incorrect Reactions	0.5 Seconds Interval 0.4 to 0.6	0.5 Seconds Interval 0.4 to 0.6

Adverse Events

Having Lunch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Skipping Lunch

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. Mathilde Kersting

Research Institute of Child Nutrition

Phone: +49-231-792210-18

Email: kersting@fke-do.de

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place