Cognitive FunctionCogniDo-GINCT02763371
Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI)
A study testing Dietary: high GI lunch and Dietary: low GI lunch in people with Cognitive Function, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function
- What is being tested?
- Dietary: high GI lunch and Dietary: low GI lunch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- all fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents and child
Who cannot join
- Metabolic diseases or special diet
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Germany Research Institute of Child Nutrition
Dortmund, Dortmund, 44225
Mathilde Kersting, Professor, 023179221018, kersting@fke-do.de
About this study
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.
Read the 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.
- Conditions
- Cognitive Function
- Being tested
- Dietary: high GI lunch, Dietary: low GI lunch
- Keywords
- high GI lunch, low GI lunch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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: 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Dietary: low GI lunch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shifting: Change of total reaction time for a) [ms]
Measuring global task-switching costs by a three-part computer trial.
- 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)
Measured: 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.
- 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)
Measured: 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.
- 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: participants were tested on two test days (T1 and T2) with one week wash out
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Institute of Child Nutrition, Dortmund
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde Kersting, Prof, Study chair, Research Institut of Child Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02763371
- Sponsor's protocol ID
- COG0416DO
- Acronym
- CogniDo-GI
- Status last verified
- May 2016
- First submitted
- 28 Apr 2016
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition Intervention Study Dortmund- Glycemic Index (CogniDo GI)
- ClinicalTrials.gov ID
- NCT02763371
- Acronym / sponsor ID
- CogniDo-GI / COG0416DO
- Conditions
- Cognitive Function
- Keywords
- high GI lunch, low GI lunch
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Research Institute of Child Nutrition, DortmundUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 5 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary: high GI lunch | Experimental | Other: Dietary: high GI lunchHigh 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: low GI lunch | Experimental | Other: Dietary: low GI lunchLow 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. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- all fifth and sixth grade students of Gesamtschule Berger Feld with the consent of parents and child
Key exclusion criteria (1 listed)
- Metabolic diseases or special diet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary: high GI lunchHigh 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. | Other | Dietary: high GI lunch |
| Dietary: low GI lunchLow-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. | Other | Dietary: low GI lunch |
Primary outcome
Shifting: Change of total reaction time for a) [ms]
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
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)
Shifting: Change of total reaction time for b) [ms
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
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)
Shifting: Change of total switch-costs [ms
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
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)
updating: change of ratio of missing [%]
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
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.
updating: change of ratio of false alarms [%]
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
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.
updating: change of mean reaction time [ms]
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
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.
tonic alertness: change of mean reaction time [ms]
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
measures the level of alertness in response to a simple visual stimulus. Mean reaction time
tonic alertness: change of deviation of reaction time [ms]
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
measures the level of alertness in response to a simple visual stimulus. Deviation of reaction time
tonic alertness:change of numbers of omission errors [n]
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
measures the level of alertness in response to a simple visual stimulus. subsidiary outcome is the numbers of omission errors.
tonic alertness:change of numbers of commission errors [n]
Time frame: participants were tested on two test days (T1 and T2) with one week wash out
measures the level of alertness in response to a simple visual stimulus. subsidiary outcome is the numbers of comission errors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathilde Kersting, Prof study chair
Research Institut of Child Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary: high GI lunch and Dietary: low GI lunch in people with Cognitive Function, run by Research Institute of Child Nutrition, Dortmund at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathilde Kersting, Prof (023179221018, kersting@fke-do.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shifting: Change of total reaction time for a) [ms] (time frame: participants were tested on two test days (T1 and T2) with one week wash out). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2016.